May 26th, 2011 by Elaine Schattner, M.D. in Health Tips, News, Opinion
Tags: Blogs, Communication, Ideas, Medical Blogs, New York Times, Reliable Health Information, Science, Social Media, Trust, Truth
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Last week Aaron Sorkin wrote for The Atlantic a piece in which he details his daily news feed, in What I Read. He’s not into blogs:
When I read the Times or The Wall Street Journal, I know those reporters had to have cleared a very high bar to get the jobs they have. When I read a blog piece from “BobsThoughts.com,” Bob could be the most qualified guy in the world but I have no way of knowing that because all he had to do to get his job was set up a website–something my 10-year-old daughter has been doing for 3 years. When The Times or The Journal get it wrong they have a lot of people to answer to. When Bob gets it wrong there are no immediate consequences for Bob except his wrong information is in the water supply now so there are consequences for us.
PZ Meyers, whose tagline for Pharyngula at ScienceBlogs is a bit crass for my taste, but with whom I often agree, writes On What’s Wrong With the Media:
This is the problem, that people blithely assume that because it is in the NY Times or the WSJ that it must be right — I’d rather read BobsThoughts.com because there, at least, poor lonely Bob must rely on the quality of his arguments rather than the prestige of his name and affiliation to persuade. Read more »
*This blog post was originally published at Medical Lessons*
May 26th, 2011 by Happy Hospitalist in News, Opinion
Tags: Adverse Events, Chantix, FDA, Get Rich Quick, Harm, Law Suits, Lawyers, Pfizer, smoking, smoking cessation, Suicide, Varenicline
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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 22nd, 2011 by Happy Hospitalist in Health Tips, News
Tags: Cool, How To Find A Vein, Internal Medicine, IV, IV Access, Nursing, PICC Line, Technology, Vein Light
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Here’s how we used to find a difficult vein. If a floor nurse could not get an IV in, they asked one of their colleagues to try. If their colleague could not find the impossible-to-locate vein, they contacted an ICU nurse. If the ICU nurse couldn’t get one, sometimes an ER nurse or a flight nurse would try. If they still couldn’t get an IV, then I would be paged to ask if they could get an order for an anesthesiologist to try. And if the anesthesiologist couldn’t figure out how to find a difficult vein, we got a PICC line with the PICC nurse or with the radiologist or I placed a central line if the patient could not wait for a PICC line.
That’s how we used to find a difficult IV.
How do we find one now? If you’re on the floor, you use one of these cheaper vein lights to find the difficult vein and place your IV. However, if you work in Happy’s ER, now you have a $6,000 Star Trek looking vein finder for those dehydrated nursing home patients and cracked out meth heads. Read more »
*This blog post was originally published at The Happy Hospitalist*
May 20th, 2011 by Glenn Laffel, M.D., Ph.D. in Health Policy, News, Research
Tags: African Americans, Commentary, healthcare, Hispanics, Institute of Medicine, IOM, Providers, Racial Disparities, Report
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It was 1999 when the Federal government first acknowledged our nation had a problem with race and health care. That year, Congress tasked the Institute of Medicine to study the matter, and the resulting report was not good. Minorities were in poor health and receiving inferior care, the report said. They were less likely to receive bypass surgery, kidney transplants and dialysis. If they had diabetes, they were more likely to undergo amputations, meaning their disease had been poorly controlled. And there was a lot more where that came from.
The IOM report was a call to action. In subsequent years, lawmakers crafted policies and established goals for improvement. Federal and state governments and numerous foundations set aside billions to fund projects. Health services researchers expanded their efforts to study the problem.
Twelve years later, we have something to show for the effort. Steep declines in the prevalence of cigarette smoking among African Americans have narrowed the gap in lung cancer death rates between them and whites, for example. Inner city kids have better food choices at school. The 3-decade rise in obesity rates, steepest among minorities, has leveled off.
Nevertheless, racial disparities persist across the widest possible range of health services and disease states in our country. The overall death rate from cancer is 24% higher for African-Americans than white people. The racial gap in colorectal cancer mortality has widened since the 1980s. African Americans with diabetes experienced declines in recommended foot, eye, and blood glucose testing between 2002-2007. Read more »
*This blog post was originally published at Pizaazz*
May 20th, 2011 by RyanDuBosar in News
Tags: Communication, Electronic Medical Records, iPhones, Oncology, Physicians, Psychiatry, Technology, Telemedicine, Video Chat, Who Uses Video Chats
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Seven percent of U.S. physicians use online video conferencing to communicate with any of their patients, according to a study of physician digital adoption trends.
The study captures a snapshot of technology, including mobile platforms, electronic health records, electronic prescribing and interaction with patients, pharmaceutical and health care market research company Manhattan Research said in a press release.
Psychiatrists and oncologists are more likely to be using video conferencing with patients. But physicians added that reimbursement, liability and privacy are still major barriers to communicating online with patients.
Major findings include: Read more »
*This blog post was originally published at ACP Internist*
