November 3rd, 2011 by Linda Burke-Galloway, M.D. in Opinion, Research
No Comments »
In a recent medical study, violent deaths of pregnant women outnumber traditional causes of maternal deaths such as post partum hemorrhage or pre-eclampsia . I am not surprised. In September 2010, I wrote an article entitled 7 Reasons Why Pregnancy Becomes a Deadly Affair after an 18 year old college student almost lost her life at the hands of her football-playing boyfriend because she became pregnant. Pregnancy is not a benign act and 50% of them are unplanned.
Dr. Christie Palladino, an ob-gyn physician at the Georgia Health Sciences University and main researcher of the study, looked at data from 17 states and found 94 pregnancy-related suicides and 139 homicides from 2003-2007. Approximately 45 % of suicides occur during pregnancy, often precipitated by Read more »
*This blog post was originally published at Dr. Linda Burke-Galloway*
May 26th, 2011 by Happy Hospitalist in News, Opinion
No Comments »
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 16th, 2011 by Dinah Miller, M.D. in Expert Interviews
No Comments »
When Roy and I were on Talk of the Nation this past week, a called phoned in to ask about her sister. The question was about care in the Emergency Room/Department, so it was a perfect Roy question and he fielded it. I’ve been playing with it since, and wanted to talk more about this particular scenario, because the scenario was very common, and the question was more complicated than it seems.
From the transcript of the show:
ANN (Caller): Hi, thank you very much. I would like to ask Dr. Roy (oh, I gave him his blog name here) a question: My sister was admitted to emergency when she cut her wrists, and the doctor on call pulled me aside and said, do you think she was trying to kill herself?
And I said – because my sister is very intelligent – I said, if my sister really wanted to kill herself, she would have done it. I think she’s asking for help.
And so he said – and so he had her see the psychiatrist who was on call, or on duty. And she spoke with him for a while. And he sent her home, saying: Well, if you need me, I’m here.
What I would like to ask Dr. Roy is, what protocol was going on there? Why did they allow that to happen? And what would you change, if you could? Read more »
*This blog post was originally published at Shrink Rap*
May 4th, 2011 by Dinah Miller, M.D. in Research
No Comments »
On Tara Parker-Pope’s NY Time Well Blog, she tells us that in places where people are the happiest, for example Denmark & Sweden, for example, have the highest happiness ranks, and the highest suicide rates. This is perplexing.
And apparently, the various United States are also ranked. New Jersey, where I grew up, is the 47th happiest state– surprising given Full Serve gasoline, good pizza, and beaches. You were looking for something more out of life? Also it has the 47th suicide rate, so the miserable apparently tough it out.
Ms. Parker-Pope writes:
After analyzing the data, the researchers found a relationship between overall happiness and risk of suicide. In general, states with high levels of life satisfaction had higher suicide rates, according to the report, which has been accepted for publication in The Journal of Economic Behavior and Organization.
“Perhaps for those at the bottom end, in a way their situation may seem worse in relative terms, when compared with people who are close to them or their neighbors,’’ said Stephen Wu, associate professor of economics at Hamilton College. “For someone who is quite unhappy, the relative comparison may lead to more unhappiness and depression.”
Dr. Wu noted that other studies have found that people react differently to low income or unemployment depending on how common it is in their community. “If a lot more other people around them are unemployed, it doesn’t seem so devastating,’’ he said.
I’m not sure one idea leads to another. Could there be another factor here? How do suicide rates correlate with the availability of mental health professionals, for example? Or with the price of chocolate in a give region? And how happy is my state?
*This blog post was originally published at Shrink Rap*
April 1st, 2011 by Glenn Laffel, M.D., Ph.D. in News, Research
No Comments »
Millions of people watch YouTube videos depicting teens injuring and cutting themselves, according to a new study. The authors conclude that the videos may serve to legitimize the behaviors as acceptable, even normal.
To assess the scope and accessibility of self-injury videos on the Internet, Stephen Lewis of the University of Guelph, and colleagues searched YouTube for keywords like “self-harm,” and “self-injury.”
They found that the top 100 most frequently viewed videos were watched more than 2.3 million times. Ninety-five percent of the viewers were female. Their average age was 25, although Lewis’ group suspects their actual average age was lower, since some YouTube viewers provide restricted content only to older viewers. Read more »
*This blog post was originally published at Pizaazz*
In a recent medical study, violent deaths of pregnant women outnumber traditional causes of maternal deaths such as post partum hemorrhage or pre-eclampsia . I am not surprised. In September 2010, I wrote an article entitled 7 Reasons Why Pregnancy Becomes a Deadly Affair after an 18 year old college student almost lost her life at the hands of her football-playing boyfriend because she became pregnant. Pregnancy is not a benign act and 50% of them are unplanned.
