June 10th, 2011 by Peggy Polaneczky, M.D. in Health Tips
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In a large multicenter study enrolling over 70,000 women, annual screening with transvaginal pelvic ultrasound and ca125 blood testing did not reduce deaths from ovarian cancer, and in fact led to an increase in complications due to screening.
Investigators in the NCI-sponsored Prostate, Lung and Ovarian Cancer (PLCO) Screening trial randomly assigned over 78,000 women age 55-64 years of age to either annual screening with transvaginal pelvic sonograms for 4 years plus CA125 testing for 6 years or usual care at 10 study sites across the US., and followed the groups for up to 13 years. Over that time period, ovarian cancer rates in the screened group were 5.7 per 10,000 person-years vs 4.7 per 10,000 persons-years in the usual care group, with 3.1 deaths vs 2.6 deaths per 10,000 person years, respectively. Over 3000 women had false positive screening results, a third of whom had surgery and 15% of those operated on had a complications from their surgery. Deaths from other causes did not differ between the groups.
The investigators concluded that annual screening for ovarian cancer does not reduce mortality, and in fact caused harms among women with fals positive abnormal results.
This is not the first study that failed to find efficacy for ultrasound and ca125 in reducing mortality from ovarian cancer, but Read more »
*This blog post was originally published at The Blog That Ate Manhattan*
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*
May 15th, 2011 by GarySchwitzer in News
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A new analysis in the American Journal of Preventive Medicine, “The Public’s Response to the U.S. Preventive Services Task Force’s 2009 Recommendations on Mammography Screening,” included a content analysis of news stories and social media posts around the time of the USPSTF announcement. The authors report:
“Of the 233 newspaper articles, blog posts, and tweets coded, 51.9% were unsupportive, and only 17.6% were supportive. Most newspaper articles and blog posts expressed negative sentiment (55.0% and 66.2%, respectively)….The most common reasons mentioned for being unsupportive of the new recommendations were the belief that delaying screening would lead to later detection of more advanced breast cancer and subsequently more breast cancer-related deaths (22.5%) and the belief that the recommendations reflected government rationing of health care (21.9%).
…
These results are consistent with previous studies that suggest a media bias in favor of mammography screening.”
Also see an accompanying editorial by Task Force members Diana Petitti and Ned Calonge.
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
April 20th, 2011 by DrRich in Health Policy, Opinion
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For some time now, numerous loved ones and dear friends have been advising and occasionally urging DrRich that, perhaps, it has become a bit inappropriate, and even unseemly, for him to continue in his longtime position as President and sole member of Future Old Farts of America (FOFA). For a not unsubstantial interval DrRich ignored this advice, feigning incipient deafness. But finally, after some focused study of that which these days returns his gaze in the mirror, and reluctantly concluding that maybe his loved ones have a point (and not wishing to seem Cranky), DrRich has reluctantly decided to resign from (and therefore disband) FOFA.
DrRich is pleased to announce that he has accepted a new position as President and sole member of Glorious Old Farts of America (GOFA).
And it is in this new capacity that DrRich has become alarmed at some of the dire warnings now being sounded by respected leaders of the Democratic Party, to the effect that the Republicans’ proposed federal budget for fiscal year 2012, released last week by Congressman Paul Ryan (who serves, DrRich believes, as Deputy Whippersnapper of the House Republican caucus), proves that Republicans are trying to kill old people. Read more »
*This blog post was originally published at The Covert Rationing Blog*
May 8th, 2010 by Edwin Leap, M.D. in Better Health Network, Opinion, True Stories
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Twice in the last few months I have encountered grief as rage. Both were in the setting of the cardiac arrest of individuals who were already very ill. One was aged, with severe, end-stage heart disease. One was of middle age, but with metastatic cancer and on hospice.
In one instance, family members became angry because we did not leave the body in the ER for eight hours so that everyone could come and pay their respects. (Which I always thought was the purpose of a funeral home.)
In another, a family was angry because we did not allow everyone back into the room during the resuscitation of their cancer-stricken loved one — a resuscitation the family insisted upon, and which required rescinding hospice status. From observing their demeanor, their presence would have caused total chaos. Read more »
*This blog post was originally published at edwinleap.com*
In a large multicenter study enrolling over 70,000 women, annual screening with transvaginal pelvic ultrasound and ca125 blood testing did not reduce deaths from ovarian cancer, and in fact led to an increase in complications due to screening.
