June 2nd, 2011 by RyanDuBosar in News, Research
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The World Health Organization (WHO) says graphic health warnings on tobacco packages are a powerful “best buy” in decreasing tobacco use and its many health consequences.
The Centers for Disease Control and Prevention outlined the research in the MMWR.
The World Health Organization (WHO) created a treaty for tobacco product labels that many countries have ratified. Among other requirements, these warnings are expected to appear on at least 30%, and ideally 50% or more, of the package’s principal display areas, and preferably use pictures.
To assess how cigarette package labels impact quitting smoking, researchers used data from the Global Adult Tobacco Survey (GATS) in 14 countries from 2008 to 2010 that had ratified WHO’s tobacco control treaty. Current smokers of manufactured cigarettes were asked whether they had noticed health warnings on a cigarette package in the previous 30 days, and whether the label led them to think about quitting smoking.
Among men in 12 of the countries and women in seven countries, more than 90% of smokers reported noticing a package warning in the previous 30 days. Read more »
*This blog post was originally published at ACP Internist*
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*
March 23rd, 2011 by RamonaBatesMD in Health Tips, Research
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Physicians and surgeons all agree on the link between smoking and postoperative complications. We don’t agree (or know) how much time is required between cessation of smoking and surgery for optimal risk reduction.
Dr.Thomas Fiala wrote a nice blog post, Smoking Cessation and surgical complications, recently discussing the 3rd reference article below.
Smokers that quit smoking before surgery had 41% fewer complications. The researchers found that each week of cessation increases the effect by 19%.
Trials of at least 4 weeks’ smoking cessation had a significantly larger treatment effect than shorter trials (P = .04).
Smokers that quit had lower rates of total complications, fewer wound healing complications, and fewer pulmonary complications.
Read more »
*This blog post was originally published at Suture for a Living*
March 10th, 2011 by Shantanu Nundy, M.D. in Health Tips, Research
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What is the leading cause of death in the United States? Heart disease? Cancer? No, it’s smoking. Smoking? Yes, depending on how you ask the question.
In the early 90s, McGinnis and Foege turned the age-old question of what people die of on its head by asking not what diseases people die of but rather what the causes of these are. Instead of chalking up the death of an older man to say lung cancer, they sought to understand the proximate cause of death, which in the case of lung cancer is largely smoking. Using published data, the researchers performed a simple but profound calculation — they multiplied the mortality rates of leading diseases by the cause-attributable fraction, that proportion of a disease that can be attributed to a particular cause (for example, in lung cancer 90 percent of deaths in men and 80 percent of deaths in women are attributable to smoking). Published in JAMA in 1993, their landmark study became a call to action for the public health community.
When looked at the conventional way, using data from the 2004 update of the original study, heart disease, cancer, and stroke are the leading causes of death, respectively. This accounting may help us understand the nation’s burden of illness, but does little to tell us how to prevent these diseases and improve health. Through the lens of McGinnis and Foege we get the actual causes of death (e.g., the major external modifiable factors that contribute to death). This analysis shows that the number one cause of death in America is tobacco use, followed closely by poor diet and lack of physical activity, and then alcohol consumption. Read more »
*This blog post was originally published at BeyondApples.Org*
February 16th, 2011 by Elaine Schattner, M.D. in Better Health Network, Opinion
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Over the weekend I went to see “The King’s Speech.” So far the film, featuring Colin Firth as a soon-to-be-king-of-England with a speech impediment, and Geoffrey Rush as his ill-credentialed but trusted speech therapist, has earned top critics’ awards and 12 Oscar nominations. This is a movie that’s hard not to like for one reason or another, at least most of the way through. It uplifts, it draws on history, it depends on solid acting.
What I liked best, though, is the work’s rare depiction of a complex relationship between two imperfect, brave, and dedicated men. At some level, this is a movie about guys who communicate without fixating on cars, football (either kind), or women’s physical features. Great! (Dear Hollywood moguls: Can we have more like this, please?)
The film’s medical aspects are four, at least: The stuttering, the attitude of physicians toward smoking, a closeted sibling who had epilepsy and died at an early age (just mentioned in passing), and the king’s trusted practitioner’s lack of credentials.
At the start, Prince Albert (young King George VI) has a severe speech impediment. It’s said that he stutters, and on film Firth does so in an embarrassingly, seemingly extreme and compromising degree. He’s the second of George V’s sons, and might or might not succeed to the throne depending on events in history, his older brother’s behavior, and his capacity to serve the Empire at the brink of war. Being effective as the king of England in 1936, and especially at the start of war in 1939, entails speaking confidently.
Prince Albert’s been through the mill with doctors who’ve tried to help him talk. Some recommend he smoke cigarettes — these, they advise, would help him to relax because they’re good for the nerves, they say. One asks him to speak with a mouthful of marbles, on which this doctor watching the film worried he might choke. Eventually Albert’s wife, Elizabeth (Queen Mother to be), finds a speech therapist in London, Lionel Logue, who uses unorthodox approaches with, by rumor, exceptional results. Eventually Prince Albert — or “Bertie” as the therapist insists on calling him — trusts and accepts help from this peculiar Australian who, it turns out, developed his methods of assisting stutterers through his work with shell-shocked soldiers in WWI. Read more »
*This blog post was originally published at Medical Lessons*
The Centers for Disease Control and Prevention outlined the research in the MMWR.
