June 15th, 2011 by DrRich in Humor, Opinion
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Q. What is the difference between a public health expert and Il Duce?
A. Mussolini was not nearly as arrogant as a public health expert.
In prior posts, DrRich related how two major publc health efforts over the past few decades – the effort to put all of us on low-fat diets, and the effort to reduce everyone’s cholesterol levels – have amounted to massive experiments, based upon insufficiently-tested assumptions and surmises and hypotheses which the experts arrogantly (and incorrectly) determined to be fact, and which were conducted upon the entire American population without its knowledge or consent.
These public health experiments cost billions of dollars, needlessly transformed large swatches of American industry, and (at least in the case of low-fat diets) likely produced significant harm to the citizenry. Furthermore, despite such results, these misbegotten public health efforts have inured Americans to the notion that it is right and proper for government experts to determine for each of us what we must and must not eat.
DrRich now feels obligated to call his readers’ attention to yet another experiment which these same public health experts have launched, an experiment under which each of us – once again – is to become an unwitting research subject, an experiment whose results are unpredictable, but which has a realistic chance of producing harm to many of us. DrRich speaks, of course, of the new US dietary guidelines, published earlier this year, regarding sodium. Read more »
*This blog post was originally published at The Covert Rationing Blog*
June 13th, 2011 by Elaine Schattner, M.D. in Health Tips, Opinion
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The June issue of Wired carries a feature on the Booming Market for Human Breast Milk. You can read about the under-the-counter and over-the-Internet sale of “liquid gold” with a typical asking price in the range of $1 to $2.50 an ounce.
Here’s a taste, from the article:
…“rich, creamy breast milk!” “fresh and fatty!”… Some ship coolers of frozen milk packed in dry ice. Others deal locally, meeting in cafés to exchange cash for commodity…
Late last year, the FDA issued a warning about feeding your child human milk from strangers. Still, the stuff’s barely regulated.
milk containers, Wired Magazine, June 2011
As much as I think it’s a good idea for women to breast feed their babies as best they can, I was pretty shocked to learn about this unregulated industry. Mainly because if a woman who donates milk is infected with a virus, like HIV or HTLV-1, the milk often contains the virus. The infant can absorb the virus and become infected. Feeding human breast milk from an unknown donor is kind of like giving a child a blood transfusion from a stranger, unchecked by any blood bank.
I’m not sure why Wired ran this story, which is admittedly interesting. Maybe it’ll push the FDA to take a more aggressive stance on this matter, as it should.
*This blog post was originally published at Medical Lessons*
June 6th, 2011 by Linda Burke-Galloway, M.D. in Health Tips
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Of the 4 million babies born in the U.S. each year, approximately 12.3 percent of them will be premature and 3.56 percent will occur before 34 weeks. Premature birth is one of the leading causes of severe handicaps and has an annual cost of approximately $26 billion dollars. Although risk factors for preterm labor have been identified, there is still no cure. As stated in a previous blog post, when the cervix becomes weak (a condition called cervical insufficiency), the patient is at risk for second trimester miscarriages and preterm labor. Also, if a patient has a previous history of premature birth then she needs her cervix measured in a future pregnancy. If her cervix is short and measures between 16 mm and 25 mm before 23 weeks, she is at risk for premature labor and delivery. The recommended treatment for a short cervix is either progesterone suppositories or injections. A few months ago, there was profound controversy over an FDA approved injection that would cost approximately $1500.00 if purchased by the manufacturer, K-V Pharmaceuticals. Bending under political pressure, K-V reduced their price to $690.00.
The more options that are available for treatment of premature labor, the greater the chances are of achieving a full term baby. In the past two months, a new study has emerged which describes a progesterone gel that reduced birth rates before 33 weeks by 45 percent and improved newborn outcomes. This is a significant result. Read more »
*This blog post was originally published at Dr. Linda Burke-Galloway*
May 26th, 2011 by Happy Hospitalist in News, Opinion
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Chantix lawsuits here we come. I’ve been prescribing Chantix and helping fill out forms for free Chantix for my patients for several years now. Chantix is one medicine used to help get patients to quit smoking right now. In fact, I even had a case presentation of a woman I warned to quit smoking for good or face a lifetime of being cross eyed.
Does Chantix help to quit smoking? Yes it does. It helps to take the cravings away in folks who use it. If you smoke, you should want to quit, based on my discussions with a tobacco farming insider. If nothing has helped, Chantix might be your last hope. As a hospitalist, I always offer Chantix therapy as part of my smoking lecture (that I bill out as smoking cessation CPT 99406 or 99407)
With the average cost of cigarettes going through the roof, the percentage of Americans who smoke has come down. For those still hanging on, taking Chantix to help quit seems like a perfect opportunity to put down the cancer sticks forever. Until the nicotine vaccine becomes widely available I just don’t think we have that many other options available.
But now it seems like Chantix lawsuits may be the next greatest get rich scheme for smokers every where. On May 19th, 2011 the FDA responded to a report from the QuarterWatch: 2010 Quarter 3 Institute of Safe Medication Practices report regarding the safety profile of Chantix . You can view the Chantix information on this pdf file starting on page 14. Pfizer sent the FDA information on several thousand Chantix adverse drug events (ADEs) resubmitted to the FDA’a Adverse Events Reporting System in July 2010 at the FDA’s request. These events reportedly had been previously submitted in a form that did not allow for a comprehensive evaluation.
These included 150 completed suicides dating back to 2007 along with hundreds of incidents of psychosis, depression and attempted suicide. In the third quarter of 2010, varenicline had 1,055 serious adverse drug events reported, more than any other drug the ISMP montitors and Chantix ranked first with twice as many deaths reported related to Chantix exposure.
Pfizer said they were unable to repond to the findings of the ISMP because of their possible involvement in future legal cases. Here is the FDA response statement to the ISMP QuarterWatch report:
In 2006, the Pfizer product, Chantix (varenicline), was FDA-approved as a smoking cessation aid. Soon after marketing, FDA became aware through its postmarketing surveillance system, the Adverse Events Reporting System or AERS, of the potential for serious neuropsychiatric events in patients taking Chantix. Subsequently, FDA began communicating about these potential risks with health professionals and patients. A list of previous safety communications can be found on the Chantix Information page.
Amid continuing adverse event reports, in July 2009, the FDA required that Pfizer update the Chantix label with the most restrictive safety labeling – a boxed warning – describing the risk for neuropsychiatric events. This warning was directly related to the association of Chantix with suicidal thoughts and aggressive behavior. In addition, in 2008, FDA required a mandatory medication guide for patients describing this risk.
In July 2010, Pfizer, at the request of FDA, resubmitted a large number of adverse event reports that were initially sent to the Agency in a way that did not allow for comprehensive evaluation. Although this resubmission included thousands of reports of potential adverse events, these events were spread out over a number of years, and had been reported to the agency periodically in summary safety reports. These reports confirm what we already knew about Chantix and would not have changed the Agency’s position on the drug’s risks and benefits, given that the data in these reports were consistent with those that led to the 2009 labeling change. At this point, based on the data, FDA does not have any new safety concerns with Chantix, though those that have been established remain under active review.
The Agency takes seriously the adverse events associated with all drugs, including Chantix. FDA continues to monitor for serious and unexpected events associated with Chantix. FDA has initiated additional postmarket safety activities. Specifically, it has required the manufacturer of Chantix to conduct a large, comparative, postmarket clinical trial assessing the safety of Chantix among other smoking cessation aids. FDA has also initiated two observational safety studies on Chantix, one with the Veterans Administration and one with the Department of Defense.
Last year, FDA became aware that a few manufacturers were submitting adverse events reports to FDA through improper channels. At that time, FDA clarified its instructions to drug manufacturers, including Pfizer, to submit adverse event reports through a channel that would allow for the adverse event reports to be entered into FDA’s Adverse Event Reporting System, a database of postmarketing adverse event reports that allows for review by the Agency’s safety staff. These instructions were clarified and put on the FDA website for AERS Electronic Submissions2.
FDA will continue to monitor the postmarket safety of Chantix and will communicate any new information as it becomes available. The Agency remains committed to monitoring the safety of drugs as they are used in the postmarket, real-world setting.
Chantix lawsuits, here we come. I think all hospitalists should be aware of these significant findings. Should we stop prescribing the drug? I think I’m done with it. I’d rather have my patients die a slow and painful death filled with morbid disability spread over many years than to have one claim I tried to knock them off with a little bloodless surgery.
Pick your poison, I guess. There’s always cold turkey available too.
*This blog post was originally published at The Happy Hospitalist*
May 26th, 2011 by Paul Auerbach, M.D. in Health Tips
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One of the most feared infectious diseases for outdoor travelers—particularly children and young adults—meningitis caused by the bacterium Neisseria meningitidis (meningococcus). The infection can appear in outbreaks, most commonly abroad, particularly in sub-Saharan Africa and China.
The infection is spread in the respiratory secretions of humans. The disease appears in many forms, the most common of which are meningitis, pneumonia, and disseminated bacterial infection. The typical presentation of meningitis is fever, headache, and a stiff neck. If the cause is meningococcus, the victim may develop a skin rash, which consists of red dots or bumps, or a flat, more patchy dark red discoloration.
If the dark red dots begin to enlarge and coalesce into large purplish bruise-like discolorations, this is a bad sign. In the worst cases, a victim can develop shock, respiratory failure, diffuse bleeding, and death. Approximately one in 10 victims of meningococcal meningitis dies. Read more »
This post, Do You Know How To Recognize Deadly Bacterial Meningitis?, was originally published on
Healthine.com by Paul Auerbach, M.D..
