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Does Accutane Cause Inflammatory Bowel Disease? The Evidence Is Weak

At home the kids’ current TV show of choice is How I Met Your Mother, supplanting Scrubs as the veg out show in the evening. Both shows are always on a cable channel somewhere and are often broadcast late at night. Late night commercials can be curious, and as I work on projects, I watch the shows and commercials out of the corner of my eye.

Law firms trolling for business seem common. If you or a family member has had a serious stroke, heart attack or death from Avandia, call now. The non-serious deaths? I suppose do not bother. One ad in particular caught my eye: anyone who developed ulcerative colitis or Crohn’s disease (collectively referred to inflammatory bowel disease, or IBD) after using Accutane, call now. Millions have been awarded.

My eye may have been caught because of my new progressive lenses, but I will admit to an interest in inflammatory bowel disease, having had ulcerative colitis for years until I took the steel cure. It also piqued my interest as these were three conditions among which I could not seen any connections. Accutane, ulcerative colitis, and Crohn’s. One of these is not like the other. Read more »

*This blog post was originally published at Science-Based Medicine*

Legal Battles Over Chantix: The Next Great Get-Rich-Quick Scheme For Smokers

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*

Tips To Reduce A Physician’s Risk Of Being Sued

A few pearls from a session on legal risks and mitigation strategies from an HM ‘11 session by Harvard’s Allen Kachalia, MD, JD:

–A relatively small number of injured patients actually file claims and get compensation.
–Many filed claims do no have actual errors in them, but the majority do.
–Poor outcomes are correlated with claims, and so is patient satisfaction. Satisfied patients are less likely to file.
–There is no evidence that hospitalists’ risk of having claims filed against them is higher than primary care internists.

To protect yourself against claims, document well. Don’t go back and change a record (you can addend, but don’t alter). Document as contemporaneously as possible. Also, “as simple as it sounds, don’t abandon your patient, and don’t stop providing necessary care,” he said. Read more »

*This blog post was originally published at ACP Hospitalist*

Surgeons Criticize Medical Tourism: You Can’t Sue If Things Go Awry

In an earlier post, DrRich offered several potential strategies for doctors and patients to consider should healthcare reformers ultimately succeed in their efforts to make it illegal for Americans to seek medical care outside the auspices of Obamacare. To those readers who persist in thinking that DrRich is particularly paranoid in worrying about such a thing, he refers you to his prior work carefully documenting the efforts the Central Authority has already made in limiting the prerogatives of individual Americans within the healthcare system, and reminds you that in any society where social justice is the overriding concern, individual prerogatives such as these must be criminalized. Indeed, whether individuals will retain the right to spend their own money on their own healthcare is ultimately the real battle. The outcome of this battle will determine much more than merely what kind of healthcare system we will end up with.

DrRich, despite his paranoia on the matter, is a long-term optimist, and believes that the American spirit will ultimately prevail. So, to advance this happy result DrRich (in the previously mentioned post) graciously offered several creative options that could be employed to establish a useful Black Market in healthcare, which will allow individuals to exercise their healthcare-autonomy against the day when such autonomy again becomes legal. His suggestions included offshore, state-of-the-art medical centers on old aircraft carriers; combination Casino/Hospitals on the sovereign soil of Native American reservations; and cutting-edge medical centers just south of the border (which would have the the added benefit of encouraging our government to finally close the borders to illegal crossings once and for all).

As entertaining as it might be to imagine such solutions, a readily available, though much more mundane, option exists today, which is to say, medical tourism. Read more »

*This blog post was originally published at The Covert Rationing Blog*

When Medical Malpractice Insurance Costs More Than Receivables

I had an interesting visit with the husband of my niece last evening. He works as an ER doctor that is self-insured group of 60 physicians that cover the ER needs of four hospitals in Clark County near Las Vegas.

What is interesting is they are self-insured to save costs. As a group, then, they know how much per patient they must collect to assure liability care for every patient that comes to their emergency rooms.

That amount is $17 per patient per visit.

Guess how much their group receives for care they render to a Medicaid patient for a “level two” visit (minor problem: ear ache, sore throat, etc.)

Fourteen dollars per visit. Read more »

*This blog post was originally published at Dr. Wes*

Latest Interviews

IDEA Labs: Medical Students Take The Lead In Healthcare Innovation

It’s no secret that doctors are disappointed with the way that the U.S. healthcare system is evolving. Most feel helpless about improving their work conditions or solving technical problems in patient care. Fortunately one young medical student was undeterred by the mountain of disappointment carried by his senior clinician mentors…

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How To Be A Successful Patient: Young Doctors Offer Some Advice

I am proud to be a part of the American Resident Project an initiative that promotes the writing of medical students residents and new physicians as they explore ideas for transforming American health care delivery. I recently had the opportunity to interview three of the writing fellows about how to…

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Latest Book Reviews

Book Review: Is Empathy Learned By Faking It Till It’s Real?

I m often asked to do book reviews on my blog and I rarely agree to them. This is because it takes me a long time to read a book and then if I don t enjoy it I figure the author would rather me remain silent than publish my…

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The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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