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 25th, 2011 by StevenWilkinsMPH in Health Policy, Opinion
Tags: Communication Skills, Denial Of Requests, Doctor-Patient Communication, Patient Satisfaction, Shared Decision-Making, When The Doctor Says No
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The short answer: No.
At least not in the context of a strong physician-patient relationship.
Many physicians have legitimate concerns about the prospects of having their salary or level reimbursement linked to patient satisfaction. I would too given the way most health care providers go about measuring and interpreting patient satisfaction data.
A major concern of physicians is the issue of patient requests – particularly the impact of unfulfilled (and unreasonable) requests upon patient satisfaction. According to researchers, explicit patient requests for medications, diagnostic tests and specialty referrals occur in between 25% to 40% of primary care visits. This figure is much higher when requests for information are factored in. Read more »
*This blog post was originally published at Mind The Gap*
May 25th, 2011 by BobDoherty in Health Policy, Opinion
Tags: ACA, Affordable Care Act, GOP, healthcare, Obamacare, Partisanship, Primary Care, Republicans
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You’d think that ensuring that there will be enough primary care doctors would not become a partisan issue. If you are a Republican congressman from Texas, or a Democratic Senator from California, you’d want your constituents to have access to a primary care doctor, right?
Apparently not: in the hyper-polarized and ideological world in which we now live, even modest steps to support primary care have been caught up in the worst kind of partisanship. The Washington Post reported recently that funding for a new expert commission authorized by the Affordable Care Act (ACA), which was to examine barriers to careers in primary care, has been blocked by Republicans:
“When the government set out to help 32 million more Americans gain health insurance, Congress and the Obama administration acknowledged that steering more people into coverage had a dark underside: If it works, it will aggravate a shortage of family doctors, internists and other kinds of primary care. So Page 519 of the sprawling 2010 law to overhaul the health-care system creates an influential commission to guide the country in matching the supply of health-care workers with the need. But in the eight months since its members were named, the commission has been unable to start any work. Read more »
*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*
May 24th, 2011 by Stanley Feld, M.D. in Health Policy, Opinion
Tags: AAFP, ACA, ACP, AMA, Anxiety, Healthcare Reform Act, Negative Perception, Obamacare, Out Of Touch, Physicians, Primary Care
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There is a widespread discrepancy between the opinions of organized medical group leaders in the American Medical Association (AMA), the American Academy of Family Physicians (AAFP), the American College of Physicians (ACP), and practicing physicians. AMA, AAFP, and ACP are part of organized medicine.
These organizations supported the healthcare reform law in 2010 and continue to support the legislation. I believe they have taken this position because they want a seat at the table as implementation of the legislation moves forward. President Obama has not paid attention to them so far and there is little evidence that he will in the future.
In March of 2010, Speaker of the House Nancy Pelosi famously said, “We have to pass the [health care] bill so that you can find out what is in it.”
Most physicians are starting to realize the implications of President Obama’s Healthcare Reform Act (ACA) (Obamacare). They are terrified about the implications for the practice of medicine.
Organized medicine is still not disenchanted with President Obama’s Healthcare Reform Act. Charles Cutler, MD, chair of the ACP Board of Governors said recently, “The medical community recognizes that so much of the ACA is good.” Read more »
*This blog post was originally published at Repairing the Healthcare System*
