Chantix May Be More Dangerous Than Smoking!

Reuters reports (here) that Chantix is "eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch," as reported by authors of a recent study (see "New study says Chantix raises suicide risks"). Here are more details as reported by Reuters:
The new study relies on adverse events from the FDA's Adverse Event Reporting (AER) System from 1998 through September 2010. They analyzed 3,249 reports of serious self-injury or depression linked to Chantix (varenicline), GlaxoSmithKline's Zyban (bupropion) antidepressant that was approved for smoking cessation and nicotine replacement products. They found that 2,925 cases, or 90 percent, of suicidal behavior or depression reported to the FDA were related to Chantix, even though the drug was only approved for four of the nearly 13 years of data included in the study. By comparison, there were 229 cases of suicidal behavior or depression related to bupropion and 95 cases related to nicotine replacement products.
The authors also looked at an antibiotic comparison group and found that adverse event reports of suicidal/self-injurious behavior or depression were otherwise "rare in a healthy population receiving short-term drug treatment."

I looked at the data in the study and carved out the data relating only to "completed suicides" and "suicide attempts" reported in the AEs studied. I figured these were the most serious adverse events. Here's a pie chart showing how Chantix compares with the competition:


In words: 88% of reported completed and attempted suicides among this group of products were found in Chantix AERs (595 Chantix cases vs. 75 Zyban cases and 6 nicotine cases). NOTE: 77% of the AERs were submitted to FDA directly by pharma companies; 40% originated with healthcare professionals and 60% originated with consumers.

This seems to be quite an increased level of risk to accept compared to the slightly better benefits of Chantix vs. the competition.

In its promotion of Chantix (among the TOP 10 DTC advertised drugs in 2010; see "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"), Pfizer cites studies that show 44% of Chantix users were "quit during weeks 9 to 12 of treatment (compared to 18% on sugar pill)." As the authors of the PLoS study point out, however, the picture is not so rosy after 52 weeks: "by 52 weeks a large majority in all groups had resumed smoking -- only approximately 25 - 27%of varenicline [Chantix] patients had remained largely abstinent compared to 17 - 19% of bupropion [Zyban] patients and 9 - 12% of the placebo group." No wonder the authors conclude "The findings for varenicline, combined with other problems with its safety profile, render it unsuitable for first-line use in smoking cessation."

Pfizer is using patient testimonials in its DTC advertising and positioning Chantix against nicotine treatment products as shown in this Chantix Web site creen shot:


If I were "Herb," I'd wouldn't be so "intrigued" by "non-nicotine" Chantix if I realized that I was 88 times more likely to attempt suicide or actually kill myself while on Chantix than if I used a nicotine patch/gum/whatever. Besides, at Herb's apparent age, stopping smoking is not likely to improve his health outcomes -- his years of smoking probably have already limited his life expectancy. Why add possible suicide to the mix?

Chantix on Facebook?
P.S. I once thought Pfizer woud be smart to use social media to help people quit smoking while on Chantix (see "Chantix: Opportunity for Social Marketing Lost?"). Seeing this data, however, I don't believe Pfizer could do it because it would be swamped by adverse event comments, especially now that Facebook requires comments to be turned on for all FB pages, including pharma-sponsored pages.

Speaking of that, I found THIS Chantix FB page (content copied from wikipedia) that does NOT have comments turned on! What's up with that?


Google to Shutter Sidewiki on December 5, A Day That Will Live Famously!

Yesterday, Google sent out an email (see here) informing users of its sidewiki service that it will close the service on December 5. Sidewiki allows users to post and read comments linked to specific web pages. It was launched in September, 2009, and I was one of the first people to use sidewiki to attach comments to a drug.com website (see "Google's Wacky Wiki is Whack! Pharma Should Demand Ability to Block It!").

In my presentation at the November, 2009, public hearing at FDA regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools, I famously called on Google to "tear down this Sidewiki" (it was the anniversary of the fall of the Berlin Wall; see transcript).

Google spent a lot of effort defending sidewiki in comments it submitted to the FDA after the November hearings, saysing "The service uses an algorithm to identify the best comments, based in part on user ratings, and seeks to display only comments that are judged to be of high quality."

I said it before (see here) and I'll say it again: Google... what a maroon!

Are Pharma Reps Important to Docs or Not?

Back in March, 2011, I reviewed a PhRMA sponsored survey of physicians the results of which PhRMA claimed shows that "nearly eight out of 10 physicians view pharmaceutical research companies and their sales representatives as useful sources of information on prescription medicines" (see "New PhRMA Survey of Physicians: Are Sales Reps as "Useful" as PhRMA Wants Us to Believe?"). If you look at a chart of the relevant data (see below), however, you see that the 80% mentioned by PhRMA includes 53% of physicians who find sales reps only "somewhat useful." Only 26% of physicians surveyed found reps "very useful."


Yesterday, I came across the Wolters Kluwer Health Point-of-Care survey of physicians, part of which looked at where physicians receive information to make decisions about diagnoses, treatment and ongoing patient care (see press release and executive summary here). This study asked physicians: "How often do you use the following sources to gain information used to diagnose, treat and care for patients?" The results are shown in the following chart:


The trends are comparable (eg, prof'l journals are rank near the top and sales reps rank near the bottom in both surveys), but you can't group the Wolters Kluwer categories "frequently" and "occasionally" together as well as you can group together PhRMA's "very useful" and "somewhat useful" categories. Because of the way PhRMA designed it's study -- using categories that can easily be combined -- they were able to spin the results favorably, whereas no such spin of the data is possible in the Wolters Kluwer survey.

So, looking at ALL the data, IMHO, the best that can be said in answer to my question is that most physicians find pharma sales reps among the least important sources of information they use to help them diagnose, treat and care for their patients.

P.S. (27-MAR-2012) I just came across another study attempting to answer the question "Do physicians find sales reps useful?" The study comes from Cegedim Strategic Data (CSD), a provider of integrated healthcare market research. CSD analyzed physician-reported diary entries of recent sales calls. Results from over 30 countries showed that overall 93.8% of physicians worldwide, both GPs and specialists, "find sales representative calls useful and of value to their practice, based on over 5.6 million product detailing mentions" (find more details here).

I believe CSD's methodology asks physicians to evaluate recent sales calls. This technique eliminates physicians who did not receive any sales calls, which skews the data to favor physicians who like sales reps to begin with. The CSD study does not compare usefulness of reps compared to other sources of information.

In any case, it's amazing how many studies are out there and how difficult it is to get a straight answer to a simple question.

Lipitor Won't Go Gentle Into that Good Generic Night

Today's Wall Street Journal reports that "Pfizer Inc. isn't rolling over and conceding the market for its cholesterol-lowering drug Lipitor after the blockbuster brand loses its U.S. monopoly at the end of the month" (read the article here). Pfizer has an aggressive co-pay card/PBM discount plan that it hopes will allow Lipitor to maintain a 40% share of the combined market for Lipitor and its generic equivalents for at least 6 months after generic brands are launched.

This has prompted me to man-handle Dylan Thomas's famous poem as an ode to Lipitor and its fight against patent expiry:

Do not go gentle into that good generic night,
Patent expiry should burn and rave at close of day;
Rage, rage against the dying of the innovator's right.

Though wise marketers at patent end know generic is right,
Because their words had forked no lightning their Rx brands
Do not go gentle into that good generic night.

Good Rx brands, the last wave by, crying how bright
Their frail market share might have danced in a greener pasture,
Rage, rage against the dying of the innovator's right.

Wild marketers who caught and sang cholesterol numbers in flight,
Learned, too late, Lipitor's fate, they grieve it on its way,
Do not go gentle into that good generic night.

Grave Rx brands, near death, that see with blinding sight
Off-patent drugs could blaze like meteors and be gay,
Rage, rage against the dying of the innovator's right.

And you, my Lipitor, there on the sad market height,
Curse, bless, your loyal patients now with your fierce tears, I pray.
Do not go gentle into that good generic night.
Rage, rage against the dying of the innovator's right.