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

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

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 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

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.