Pfizer Throws In the Lipitor Marketing Towel. Repercussions in Job Market Will Be Swift

Despite Pfizer's heroic and unprecedented effort to maintain Lipitor's market share after expiry last November and after spending "more than $87 million promoting the medicine, the world's biggest drug company is quietly giving up on its once-great cash cow for good because more generic versions will soon be going on sale" (see this Wall Street Journal story: "Farewell after all, Lipitor").

As I reported here on Pharma Marketing Blog on May 2 (see here), Pfizer's Lipitor co-pay card/PBM discount plan failed to meet its goal of maintaining a 40% share of the combined market for Lipitor and its generic equivalents for at least 6 months after generic brands are launched. As reported in the WSJ (op cit), Lipitor's U.S. market share is 33% after 5 months (more generics will come on the market after May 31).

Although Pfizer will say that its program was a succes, the program has not met its sales goal and is considered a public relations failure by some people in the industry. A pharmaceutical marketing VP attending a recent conference referred to my blog posts "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE" and "Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?"

But after spending more than $87 million promoting Lipitor in recent months, Pfizer officials told The Wall Street Journal that the company is "no longer negotiating new contracts to sell Lipitor to health plans, which are signing up to sell generic versions at far lower prices. The company recently stopped sending sales representatives to promote Lipitor to doctors and halted advertising in print, on television and online, which once commanded a $271.9 million yearly budget." Here's a chart showing Lipitor's direct-to-consumer (DTC) advertising budget over the past 9 years:

[Note the minuscule proportion allocated to "Internet" ad spending. I cannot see from this chart what the $ amount is!]

The elimination of $220 or so million in Lipitor DTC advertising will, I predict, result in a 3% drop in overall DTC advertising in 2012 compared to 2011 (see "Lipitor Holds Key to DTC Ad Spending in 2012"). But that is only the tip of the Lipitor marketing budget, which totaled over $660 million in 2010. Included in that number is marketing to physicians and samples (see here).

When that much money is taken out of the Rx brand marketing equation, there are bound to be repercussions within Pfizer itself and within marketing communications companies that provide services to Pfizer. Meaning, of course, jobs will be lost. Perhaps that correction has already occurred. Or perhaps there are more layoffs to come.

Have You Met Turbo & Scott? FTC May Want to Meet this eBook for Children Sponsored by Novartis

I just found this tweet from @Novartis:

"US only: Have you met Turbo & Scott? Visit http://t.co/yJDtSvhQ to read the TSC eBook or download Barks and Crafts"

At first, I thought this would be some kind of Rx branded Web site because it was for "US only," which usually means there's some direct-to-consumer (DTC) Rx product information on the site or closely linked to it. But there isn't any hint of a drug mentioned anywhere that I can find.

It's really a site designed for young children who have TSC, "which stands for three big and hard-to-pronounce words, Tuberous Sclerosis Complex."

NOTE: Novartis probably markets the only drug approved by the FDA for treatment of TSC (see press release). Hence, even though the drug is not referenced on this site, FDA may regulate the site as if it were marketing that drug. European regulators also may feel that the TSC site violates their regulations regarding DTC communications.

The eBook is beautifully illustrated and written in the simple language that a child would use. In fact, it's a story told by Turbo, the stuffed dog friend of Scott who is "a real boy and [Turbo's] best friend." Scott has TSC.

I've never heard of TSC before, but apparently, it is a pretty serious hereditary condition that can cause seizures and may require Scott and other kids with TSC to be examined and treated by as many as SEVEN different specialists: Neurologist, Ophthalmologist, Pulmonologist, Nephrologists, Psychiatrist, Cardiologist, and Dermatologist. That's a lot of "gists!" The ebook does a good job explaining to kids what these doctors do.

But what the site does NOT do well (IMHO) is comply with the U.S. Children's Online Privacy Protection Act (COPPA). COPPA "applies to operators of commercial websites and online services directed to children under 13 that collect, use, or disclose personal information from children." Such sites may not collect personally-identifiable information from children without the consent of parents (see COPPA FAQs).

The URL in the tweet above resolves to this URL: http://www.tuberous-sclerosis.com/patient/ebook/ebookhome.jsp which displays this page:

There is a notice from Novartis at the bottom of the screen, which states "Use of this website is governed by the Terms of Use and Privacy Statement. Copyright ©2012 Novartis Pharmaceuticals Corporation. All rights reserved."

The privacy statement clearly states that "Novartis will not knowingly collect, use or disclose personally identifiable information from a minor under the age of 13, without obtaining prior consent from a person with parental responsibility (parent or guardian)." However, any child (including me) can click on the "Send to Friend" tab and enter his/her name and email address as well as the email address of a friend:

Novartis says "The email addresses you furnish will be used solely to notify the recipient of the link to this page and that you have requested it to be sent. The addresses will not be retained or reused." Since the information is not "retained of reused," this "Send to Friend" feature may be eligible for the "one-time exclusion" allowed by COPPA.

However, another feature of the site allows children to send an email message directly to TSC.Story@novartis.com.

On that page Novartis says: "TSC.Story@novartis.com is to be used to show your interest in further information. We look forward to receiving your email. The personal email information you submit will be used to deliver information about TSC and the TSC eBook program only. By submitting your information you agree to receive information via emails. Please be assured that although we share your information with third parties who work for us on these activities, neither Novartis nor third parties working on our behalf will sell or rent your personal email information. You may unsubscribe at any time by clicking here and specifying Unsubscribe in the subject of the email."

This is clearly an attempt to collect personal information from the children at whom this site is aimed.

I've sent an email to TSC.Story@novartis.com requesting more information about TSC. I signed it "Johnny Mack." So far, I haven't received any response.

P.S. There's a bit of confusion about who is responsible for collecting personal information on the site. I found this statement: "The TSC eBook is sponsored by Novartis Pharmaceuticals Corporation. With the exception of www.TSCStory.com and www.FacingTSC.com, the websites mentioned in this eBook are independently operated and not managed by Novartis, which assumes no responsibility for any information they may provide."

Update from Corporate Marketing Team

                                                                                

Dear Speakasians,

This is to inform you all that a website by the name of www.speakasiaexit.com has recently put up an exit application form for all those panellist who wish to leave our family.

The company would like to state that it has no connection with the above mentioned site whatsoever. This website has been put up by certain vested interests who wish to derail the process of the exit options. Suitable legal actions have been initiated against the concerned for this gross inappropriate action.

The company as usual will continue communicating with all of you through its own blog site. Speakasiaonline.marketing.blogspot.com .

Warm Regards,

SpeakAsia Corporate Marketing Team

Is 38 Hours Quick Enough to Respond to a Potentially Serious AE Tweet?

Subtitle: JNJ Responds to Adverse Event Reported Directly to @JNJComm via Twitter

There are probably more than 100 pharmaceutical company Twitter accounts such as @JNJComm, which posts news and information from Johnson and Johnson's Corporate Media Relations team (Devon Eyer - @DevonEyer - and Bill Price - @wtprice3).

With such a conspicuous presence on Twitter, I am amazed that I haven't noticed very many complaints from consumers directed at these accounts. I'm specifically talking about complaints that relate to adverse drug reactions. Pharma companies are deathly afraid of having to deal with such complaints via social media mostly because of the FTEs that may be required.

But, really, how big a problem is it? I haven't done a quantitative analysis, but I suspect that if @JNJComm gets one such complaint per month, that would be a lot.

This month, I noticed a complaint made to @JNJComm by @CapeFearPhoto (aka "Chad Heavilyarmed"). At 12:06 AM on May 2, 2012, @CapeFearPhoto tweeted:

"Hey @JNJComm Can we talk about #sideeffects from your Janssen Pharm products? Please? #stillvomiting #nightterrors #nothappy #NUCYNTA #FAIL"

About 20 minutes later at 12:21 AM, @CapeFearPhoto sent another tweet directed to @JNJComm:

"Seriously @JNJComm I know you guys are probably sleeping. Kinda wish I could. Let's chat about #NUCYNTA drug trial results and #sideeffects"

Yes, Devon and Bill were probably asleep, but @JNJComm did finally respond at 1:59 PM on May 3, 2012:

"@CapeFearPhoto Thanks for the message; we'd like to learn more about your situation. Please call 800-526-7736 or visit http://ow.ly/1LCBtn"

The link leads to Janssen Pharmaceutical's "Tweet Response" page, which was "last modified" on Apr 13 2012. This is the first time I've seen such a Web page. I wonder if other pharmaceutical companies have similar pages to which they direct Twitter users? The page informs visitors that:

"This is in follow up to your recent tweet regarding our product. As a pharmaceutical company, we are required to inform the Food and Drug Administration of any adverse experiences associated with our products. Therefore, our Global Medical Safety department would like to learn additional information about your experience and hope you will contact us at janssenmedinfo@its.jnj.com or at 1-800-526-7736."

At 2:20 PM on May 3, 2012, @CapeFearPhoto responded with this tweet:

"I will @JNJComm! #Nucynta gave more adverse reactions than anything I've ever taken and almost drove me to suicide. #horribleterriblebad"

I'm not going to get into whether or not this qualifies as a reportable adverse event. But it should be noted that the tweet was directed specifically to @JNJComm and that @JNJComm responded PUBLICLY via Twitter within 38 or so hours.

Perhaps JNJ could have responded sooner. After all, the "Tweet Response" page was available and the tweet that @JNJComm eventually sent out could have been a MLR pre-approved "boiler plate" response all ready to go. Or was it? Maybe it took @JNJComm so much time to respond because it never before received such a message and had to craft an appropriate response and get it approved before it could be sent!

Whatever, just another pharma social media first for me to document. Here's a screen shot of the relevant conversation for the record:

Obama's Executive Order Spurs Drug Industry to Cooperate with FDA to Ease Drug Shortages

This week marks the six-month anniversary of President Obama signing an Executive Order to help FDA in its efforts to prevent and resolve prescription drug shortages. Following the Executive Order, FDA sent out letters to drug manufacturers asking them to "voluntarily report to FDA if they saw the emerging potential for a drug shortage."

"I am both amazed and delighted to see the progress that’s been made," said FDA Commissioner Margaret Hamburg in a blog post (here). "Early notification to FDA of potential disruptions in drug supply has made a huge difference in our efforts -- and the numbers really tell the story [see chart below]."

"Since reaching out to industry, there has been a six-fold increase in early notifications from manufacturers," said Hamburg. "Also in that six month timeframe, we have been able to prevent 128 drug shortages, and we’re seeing fewer numbers of shortages occur – 42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year. This data is a testament to how FDA exercises flexibility and discretion in much of our work on drug shortages and the importance of strong collaboration and constant communication with industry, health professionals, and patients."

According to the above chart, FDA projects that there will be only about 130 actual drug shortages reported in 2012 compared to 250 reported in 2011 and that FDA-industry cooperation will have prevented about 100 additional shortages. By FDA estimates, even if it didn't prevent any shortages, the number of drug shortages in 2012 would be about 230 compared to 250 in 2011. That is, FDA envisions the trend in drug shortages reversing with or without FDA intervention.

But with FDA and industry cooperation, there were only 42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year.

Pharma Support of CME Infographic

Pharma support of CME continues to decline, but at a slower rate.

"Other" Sources of Revenue (eg, registration fees, grants from gov't or independent foundations) have taken up the slack and then some so that 2010 revenue actually increased compared to 2009!

The distribution of CME income by source as a percent of the total looks more like the "old" days around the turn of the century.

A big surprise is the drop in percent of physicians opting to participate in online CME programs.

Source of Data: ACCME Annual Reports

Pfizer's Lipitor Co-pay Card/PBM Discount Plan Fails

Yesterday, an attendee at the Marcus Evans PharmaMarketing Summit here in Chicago asked if Pfizer's innovative plan to extend the life of its Lipitor franchise after patent expiration was a public relations failure. He was referring, in part, to my blog posts "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE" and "Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?"

Pfizer had hoped that its aggressive co-pay card/PBM discount plan would 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 (see here). Today, I read in the Wall Street Journal that Pfizer 2012 first-quarter profit declined 19% (vs Q1 2011) as sales of Lipitor, tumbled 71% in the U.S.

"Global sales of the drug fell 42% to $1.4 billion, including $383 million in the U.S. The branded Lipitor's U.S. prescription market share has declined to just over 30%, according to analysts, as competing generic versions from Watson Pharmaceuticals Inc. and Ranbaxy Laboratories Ltd. have taken market share" (see here).

You could speculate that Lipitor sales would have dropped even further and faster if it were not for Pfizer's Co-Pay discount plan, which also involved pharmacists dispensing Lipitor even when a generic version was prescribed by the doctor.

Or you could say that the plan failed to meet its goal, ie, 40% of U.S. market sales. There's still a month or 2 before we reach the 6 month mark and sales of Lipitor can drop even further before then.