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Increasing Government Oversight Of IRBs Could Help Prevent Seeding Trials

I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go.

Recall that in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements.

isthatamisprint 300x200 Neurontin: Seeds of DiscontentNow, it has come to light that Parke Davis’ marketing department sponsored a Seeding Trial of Neurontin back in the day—that is, a trial portrayed deceptively as a patient study but whose real aim was to encourage prescribers to use the drug.

The trial was STEPS, the ‘Study of Neurontin: Titrate to Effect, Profile of Safety’ trial. More than 772 physician ‘investigators’ and 2800 patients participated in STEPS.

The stated objective of STEPS was to study the safety, efficacy and tolerability of Neurontin. However, after reviewing documents compiled for a pair of lawsuits against Pfizer and its subsidiaries, Joseph Ross and colleagues concluded that the actual objective was to increase prescribing rates by ‘investigators’ in the study. Neither the ‘investigators’ nor their patients were informed about the real purpose of STEPS.

The trial worked, from Parke-Davis’ point of view. Read more »

*This blog post was originally published at Pizaazz*

Government Grants Support Meta-Analyses That Can Spawn Mega-Misinformation

It was another headline busting study this week: Pfizer Drug Tied to Heart Risks – a provocative title no doubt fed to the media from the publisher: the Canadian Medical Association Journal. The study was yet another meta-analysis that culled the world’s literature in an attempt to determine if a trend could be found that might implicate Chantix as a causative agent for and increased incidence of heart disease in smokers.

On its surface, the study sounds authoratative, analyzing “14-double-blind randomized controlled trials involving 8216 participants” ranging in duration from “7 to 52 weeks.”

Never mind that 57% (25) of adverse events were weighted from one study and that none of the 14 studies had odds ratios that did not cross the unity line.

Despite this, the lead author concluded:

Despite the limitations of our analysis, our findings have potential regulatory and clinical implications.

Sorry, this is not correct. There are no clinical implications of this trial. Like all metanalyses, meta-anaylses simply cannot determine cause and effect. (Note to main stream media: are you folks listening?!?)

That being said, there’s another concern I have Read more »

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

Awkward Timing: Actor Featured In TV Drug Commercial During His Own Murder Movie

You may recall, I have a beef with Madison Avenue ad agencies that keep serving up the same New York actors in television commercials for different illnesses. I take it personally. The woman with cancer also has asthma. The man with arthritis also has erectile dysfunction. I feel bad for them!

Last night the quest by an actor to find work got ridiculous for me as my wife, Esther, and I were watching one of our favorite shows, “Criminal Minds,” on CBS. It was a particularly violent episode where a Bonnie and Clyde-type couple shot their way across Montana and proved to be the sickest of cold blooded killers. As the story develops, both the young man and the young woman were abused as children and their plan becomes to mete out retribution to the parents who ruined their lives.

Late in the show the young woman confronts a gray haired man in his 50’s behind the counter at his service station-convenience store. It was her father. She points a gun at him while he pleads for his life. I turned to Esther and said “I know that man! Where do I know him from?” Esther didn’t know and I couldn’t remember. Back on the screen things go from bad to worse, and while the young woman hesitates, her boyfriend sends the father to the hereafter. It was so sad. Where do I know that guy from???? Read more »

*This blog post was originally published at Andrew's Blog*

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*

Industry Influence Is “An infection”: International Criticism Of Pfizer-Funded Journalism Workshops

Next week, the National Press Foundation offers an “all-expenses-paid, educational program on cancer issues” for journalists, with all expenses paid by Pfizer. I’ve written several times about my criticism of this approach.

The National Press Foundation has offered to let me speak at next week’s event or at a subsequent all-expenses-paid program for journalists on Alzheimer’s disease also underwritten by Pfizer.

I’m unable to attend either event because of prior commitments, but suggested to NPF that they ask Merrill Goozner to speak instead. He’s right in Washington, has written and lectured about conflicts of interest in healthcare, and was available. Goozner told me he has not been contacted. So, since I can’t attend and since critical voices probably won’t be represented at the first workshop, I have posted some video clips of what others might have said if given the opportunity. Read more »

*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*

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IDEA Labs: Medical Students Take The Lead In Healthcare Innovation

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Latest Book Reviews

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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

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