FDA Caught Speeding. Puts Public Safety at Risk.

"An FDA effort to speed approval of new medicines allowed drugs for stroke prevention, cancer and multiple sclerosis onto the market without proper safety analysis, according to two drug-safety experts," reports the Wall Street Journal in a review (here) of a "viewpoint" recently published in JAMA.

Peter Pitts of Drug Wonks says: "As usual, Janet Woodcock [Director of the Center for Drug Evaluation and Research at FDA] places the matter in the appropriate perspective. 'I'd like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks,' Dr. Woodcock said. "The cancer community in particular says we haven't used accelerated approvals enough.'" Pitts adds this zinger:

"Here’s the truth -- there is no such thing as a 'safe' drug. It's the patient who must understand the risks required to achieve the benefit. That’s why the patient voice must be heard during all phases of the regulatory review process."

Unfortunately, I don't think Pitts actually read the piece in JAMA. The drug safety expert authors of that piece (Thomas J. Moore and Curt D. Furberg) did not claim that drugs approved by the FDA should be "safe." They made the argument that accelerated approval by FDA of several powerful drugs with UNKNOWN safety issues were no better at improving outcomes than drugs currently on the market whose safety issues are well-known.

"Although enabling new drugs with a favorable benefit-to-harm balance to become available to patients more rapidly is a laudable goal," said Moore and Furberg, "the underlying question is what public health risks are taken when drugs are approved for widespread use while important safety questions remain unanswered."

The authors cite several specific drugs that were fast-tracked for approval without adequate safety information available. I'd like to focus on one: Dabigatran for prevention of stroke. Dabigatran is marketed as Pradaxa by Boehringer Ingelheim (BI).

According to Moore and Furberg, Pradaxa benefited from "3 different FDA policies promoting innovation. This drug received both Fast Track and Priority Reviews and was studied in a single large phase 3 trial rather than in at least 2 pivotal trials, as normally required...Within less than a year of approval, 1 survey showed that dabigatran accounted for more serious adverse drug events reported to the FDA during the second quarter of 2011 than any other regularly monitored drug. Risk of hemorrhage was prominent in older patients (median age, 80 years), a subgroup for whom declining kidney function or other factors may have increased bleeding risk. Both a manufacturer package insert revision and the European Medicines Agency have called for closer monitoring of kidney function, a needed step because even moderate kidney impairment increases dabigatran levels more than 2-fold. In addition, unlike warfarin, no antidote is available for use in bleeding emergencies related to dabigatran. Evidence was beginning to emerge that dabigatran-related bleeding— whether from trauma or as an adverse effect—may be more difficult to treat than warfarin-related bleeding."

Couple this safety issue with the promotion of Pradaxa in the media as a "super pill" and a "revolutionary drug" (see "Bad Journalism or Bad Pharma?") and you end up with a real public safety issue that patients should be concerned about. BI itself stoked this Pradaxa-mania (read, for example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons" and "Full BOEHR(inger) Social Media Reporting of RELY Trial Results").

Sadly, Woodcock may have heard from "patient advocates" paid by pharma companies to testify before the FDA, but who advocates for the patients harmed by drugs like Pradaxa? Their stories are locked in the FDA's adverse event database, which is not generally cited during drug approval Hearings at the FDA.

Not to mention the impact of DTC advertising on the public's willingness to accept greater risk:

How Johnson & Johnson Uses Twitter for Patient Support: A-plus for Effort, D-minus for Sharing

Every day, I get a synopsis of tweets and newsfeeds from selected pharma companies that I am following (see "News Direct from the Pharma Industry"). Lately, I've been noticing a number of tweets from Johnson and Johnson (@JNJComm) that are direct responses to complaints from consumers about its products. In some cases, complainants have had an extended conversation with JNJ.

However, you won't find these conversations if you look at the @JNJComm Twitter timeline here but you can find them in the PMN Forum archives here. More on this later. Right now I'd like to focus on one of these conversations.

@hiltmon (Hilton Lipschitz) complained about an Acuvue contact lens problem in a tweet posted to @JNJComm. @hiltmon said: "@JNJComm, could you please fwd this to Acuvue team: See the hole in the lens (top right), happened twice now. Thanks. pic.twitter.com/50ML8IrT" The link leads to this photo:

Whether or not this could be classified as a legitimate "adverse event," is a matter for debate, but JNJ responded as if it were: "thanks for alerting use. Please call us at 800-843-2020. It's important that we fully understand what occurred. Thanks! ^DE" Here's a screen shot of the full exchange:

I am not sure what "^DE" means. It appears that JNJComm uses it only at the end of responses to these sorts of complaints. I assume it allows some kind of tracking or followup. [Actually, it indicates the author - in this case Devon Eyer; see UPDATE at the end of this post.] In any case, the end result was one happy (I assume) customer.

I cannot find a legitimate Acuvue Twitter account, although the brand does have a Facebook page. After a quick scan through the Acuvue FB page, I can find no consumer complaints or conversations like the above. It's all good brand "conversations" over there on the Acuvue FB page :-)

The above Twitter conversation might be considered a "brand conversation," which is what brand marketers would like to see (although they would like positive rather than negative conversations about their products). So, JNJ corporate communications people are having these brand support conversations via Twitter, but the brand people -- who presumably manage the FB page -- do not. That's telling in respect to the question I asked in a previous post: "Who's Your Social Media Daddy?"

This conversation is somewhat hidden from most of the nearly 20,000 @JNJComm followers. As I mentioned above, it does not appear in @JNJComm's Twitter timeline because each tweet begins with "@". That makes it a personal conversation in Twitter. Unless you access @JNJComm's Twitter RSS feed as I do, you won't see these tweets. That's unfortunate, IMHO, because it means that the power of social media (e.g., sharing content with followers) is sidestepped. In this case, other consumers may not learn about important safety and other information about Acuvue lenses. Public health would be better served if everyone could learn from the conversation (e.g., the batch number of the faulty lenses).

Of course, it also means that these conversations may not be picked up by the media -- presumably the main audience for @JNJComm and other pharma corporate Twitter accounts -- or by regulators who may like more information about faulty medical products.

UPDATE: ^DE indicates that the @JNJComm posts were written by Devon Eyer, Director, Corporate Communications, Social Media at Johnson & Johnson (see her LinkedIn profile here).

I have included Devon in my list of contenders for the 3rd Annual Pharmaguy Social Media Award. You can learn more about this award here and/or vote for your favorite here.

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:

Mining FDA's AER Database: Heaven for Hypochondriacs, Hell for Pharma

A story in yesterday's WSJ Health featured AdverseEvents Inc., a start-up company that has streamlined the FDA's "often impenetrable" adverse drug event database and made it easy to search the adverse-event reports (AERs) for more than 4,500 drugs, free and online (see here).

I interviewed Brian M. Overstreet, founder and president of Adverse Events, last September on my Pharma Marketing Talk show. You can use the widget below to listen to that interview>



The pharmaceutical industry is a bit nervous about consumers getting easy access to FDA's "hidden" treasure trove of AERs:

Kate Connors, a spokeswoman for the Pharmaceutical Research & Manufacturers of America, which represents most drug makers, said the group isn't familiar with AdverseEvents and believes the FDA is the most appropriate source of information. "We think it's important for this information to be framed within context and to be properly evaluated," she says.

But the FDA passes the buck as far as being the authoritative source for AE info. As reported in the WSJ, FDA's site warns that its AER files "cannot be used to calculate the incidence of an adverse-event in the U.S. population." For consumers who want more information on drug side effects, "the best source is to read the product label and talk to your doctor or pharmacist," says Gerald Dal Pan, director of surveillance and epidemiology in the FDA's Center for Drug Evaluation and Research.

"Read the product label"! That's a joke, right? FDA hasn't made much progress simplifying drug labels either because of industry resistance or being forced to do endless studies on the issue (see, for example, "FDA Plans to Test New Standard for Easy to Understand Rx Labels").

Meanwhile, how risky are Rx drugs? I invite you to take "Harry's Drug Risk Parlor Game" and rate the overall risk of Rx drugs (you will be able to see the results to date afterward).

[Hat Tip to @Pernajl for the "heaven for Hypochondriacs" part of this blog post title.]

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?

The British Pharmaceutical Industry Issues Social Media Guidance for Adverse Event Reporting

Once again the Brits have beaten the US in issuing useful guidelines for social media use by the pharmaceutical industry! As I reported back in April, 2011, the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), published "informal guidance" providing the drug industry advice on how to use online communications (see here).

I learned today from a tweet by @dawidge (a Pfizer employee) that the ABPI Pharmacovigilance Expert Network (PEN) published GUIDANCE NOTES ON THE MANAGEMENT OF ADVERSE EVENTS AND PRODUCT COMPLAINTS FROM PHARMACEUTICAL COMPANY SPONSORED WEBSITES (find the document here).

The guidance addresses three different ways that pharmaceutical companies may learn of adverse events (AEs) through social media:

1. "Listening in" -- Monitoring social media sites allows a company to "listen to" or "see" what the public are discussing, saying or sharing about the company itself, diseases, conditions, and treatment options.
2. "Giving out" -- Many social media sites allow companies to initiate one-way communications to share important messages with the public, where interactive dialogue is not permitted or practical.
3. "Engaging with" -- Engaging, exchanging and participating in interactive communication with the public. This type of activity is performed in both company and non-company sponsored sites.

I found a couple of interesting suggestions in these guidelines:

Companies Should Declare Involvement and Responsibilities
The guidelines state that "The company’s involvement in the social media site must be transparent to the users." Even when just "listening in," the company "should declare its presence by registering on the site using the company name." The ABPI concedes that "this may not be practicable or possible for buzz-monitoring type activities" that are usually carried out by third parties. "In addition," says ABPI, "it is also recommended that the company disclose the length of time it intends to sponsor the site (if known) and how it intends to screen and use any user-generated content."

ABPI also recommends that regulated companies "ensure that all staff involved in the social media channel are appropriately trained for performing pharmacovigilance related activities." That would include moderators and third-parties hired by the companies.

These are EXACTLY the kinds of disclosures from pharmaceutical companies that I suggested in a previous Pharma Marketing Blog post (see "Fair Social Media Practice Principles: Rules for Third-Party Engagement in Patient/Physician Social Networks" and respond to my survey).

Collecting AEs on Social Media Sites
ABPI recommends that company owned sites "be designed to facilitate the pharmacovigilance process" through use of "free text fields" and access to "internal/external reporting based tools which allow users to report suspected adverse drug reactions." One such tool might be a Adverse Event Reporting Widget (see "Using Social Media in a Crisis: Distribute a Product Safety Widget Is One Idea").

ABPI says that details of ALL AEs "should be collected and document, regardless of:

• Seriousness of the event
• Whether there is an identifiable reporter
• Whether any adverse events are listed in the product’s Summary of Product Characteristics
• Whether a definite causal relationship or link to the product has been stated
• Whether the stakeholder or patient has already reported the event to the competent authority or says they have reported it to the company"

That's quite different than what commenters from the US drug industry told the FDA (see "Social Media and the Future of Adverse Event Reporting"). The US industry said such a collection regime would be too onerous.

Regarding the identity of the reporter of an AE, ABPI says an e-mail address would be considered acceptable and even a screen name would be acceptable IF the screen name allowed for contact to be made. ABPI recommends companies implement "a formal site registration process" that can be utilised to obtain information enabling regulated companies  to "identify and contact users in order to validate and follow-up on safety information." During registration, users should give consent for the company to follow-up with a user should they report AEs, says ABPI. "It should also be made clear that personal information may be processed on internal company databases and sent to regulators."

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Did Boehringer Mishandle This Adverse Event Report on Twitter?

I follow many pharmaceutical companies (and employees of pharma companies; eg, these people) on Twitter. @BoehringerUS is one of them. To keep track of these accounts, I cross-post the tweets to this Pharma Marketing Forum (News Direct from the Pharmaceutical Industry), which automatically sends me a daily email message telling me what's been posted there. It's a good way for me to filter through all the tweets from the over 2,500 people I follow on Twitter.

Today, I received notice of the following tweet from @BoehringerUS:

@professorbunbun Please call Boehringer Ingelheim @ 800-542-6257 option 4 to report adverse events or product complaints.

I traced back the Tweet timeline of @professorbunbun -- "Meredith: Just a girl trying to aclimate to the 21st century corporate world after three years as Betsy Ross in 1776." -- to find the tweet that triggered that reply from @BoehgingerUS:

Also @boehringerus your drugs, (Mirapex,) didn't work and made my mom's hair fall out so that is a double-strike as far as I am concerned.

Here it is in context via Twitter:

Does this tweet by @professorbunbun satisfy FDA's four criteria for a REPORTABLE adverse event (AE), namely:

1. An identifiable patient - Meredith's mom
2. And identifiable reporter - Meredith
3. A suspect drug, biological product, or device - Mirapex
4. An adverse event or fatal outcome - hair loss

The second criterion -- identifiable reporter -- is the problem. We don't know the true identity of "Meredith."

So, Boehringer did not have enough data to issue a report to the FDA, which has not (yet) issued any guidelines on what constitutes an "identifiable reporter" on social media. For more on that topic, see "Uncertainties Regarding Reporting Adverse Events Found on Social Media Sites."

Instead of telling @professorbunbun to call an 800 number and press "4" to report the adverse event, @BoehringerUS could have been more proactive and asked Meredith to identify herself so that an AER (adverse event report) could be made to the FDA. However, it would not have been a good idea to ask Meredith to reveal her identity via a public reply on Twitter. @BoehringerUS, however, could have sent @professorbunbun a direct message (DM), which is NOT public and Meredith could have DM'd a reply. But that would require @professorbunbun to be a Twitter "follower" of @BoehringerUS and vice versa. It's not likely they follow each other, although the two parties could have agreed to do so.

All this, however, is probably not the job of the people behind @BoehrinerUS, who are mostly public relations/corporate communications people -- although I believe AEs SHOULD be their concern (see "Adverse Event Reporting -- Pharma Puts Profits Before Patients. A Missed Opportunity"). Hence, the tweet telling @professorbunbun to call the 800 number.

Making a public announcement via Twitter on who to contact to report an adverse event is probably a good idea. Perhaps pharma companies should make such tweets from time to time even if they are not responding to a potential reportable AE tweet.

But I question the use of an 800 number in this age of technology, especailly when you are communicating with technically savvy people who use Twitter! Why doesn't Boehringer -- and other pharma companies -- have a more convenient online mechanism for reporting adverse events DIRECTLY to the FDA as I suggested in this post: "Tit-for-Tat Tithe on Pharma Marketing. How It Can Work."

BTW, the AE exchange between @professorbunbun and @BoehringerUS began almost as an after thought prompted by a different sort of adverse event suffered by Meredith herself: the failure of a Boehringer "resistance band" at the Parkinson's Unity Walk (Boehringer was a Diamond Sponsor). Here's @professorbunbun's tweet about THAT adverse event:

Also, @boehringerus next time you hand out resistance bands at @unitywalk it might be a good idea to make sure they don't snap at first use

Adverse Event Reporting -- Pharma Puts Profits Before Patients. A Missed Opportunity

By now you should have heard that the Supreme Court recently ruled that investors can sue pharmaceutical companies for failing to disclose reports of adverse events even if the evidence is not "statistically significant" (see "Supreme Court Allows Investors to Sue Pharmacos Over AE Reporting Lapses").

In a brief to the court, PhRMA (the US pharmaceutical trade association) said "A collection of adverse event reports that is not statistically significant does not permit a reasonable inference that a particular medicine actually caused the reported adverse event" (the brief is attached to the post cited above).

But what is "statistically significant?" According to PhRMA, "The statistical significance standard requires disclosure only once a correlation between an adverse event and the subject product can be reasonably inferred to be causal. It is only at that point that a manufacturer or regulatory body might react to adverse events, that a medicine’s sales would be threatened, and that a rational investor might consider this information in making investment decisions."

"Writing for the unanimous court," NPR reports, "Justice Sonia Sotomayor said that medical researchers and the FDA often reach initial conclusions based on evidence that is not statistically significant."

"The decision will make compliance with the securities laws more difficult" for corporations, said James Martin, who filed a brief in the case on behalf of lawyers who represent corporations.

The decision will also make it more difficult for pharma marketers to engage in the social media realm, where the adverse event boogey man has often been cited as an excuse for not engaging consumers about product issues.

When the adverse event reporting issue comes up during industry conferences such as this week's CBI's iPharmaConnect, there are always pharma people in the audience who wish their companies would embrace adverse event communication with consumers/patients as a way of supporting the users of their products. During my panel discussion -- "Utilization of Social Media -- How Far Is Too Far" -- one pharma employee in the audience had this to say:

"I think as an industry that we should really turn this [social media] adverse reporting [issue] on its head and look on it as an INCREDIBLE opportunity to really engage with the ultimate end user who is really the most important person [my emphasis, I think] and use it as an opportunity to find out WAY more than we ever do about how [our products] really affect their lives. ...I think this [pharma aversion to dealing head-on with AER in social media] is EXACTLY why people don't like the pharma industry -- because we're always doing things that are SO secret -- 'Oh, we can't talk about that.' -- it's ridiculous! We save people's lives and we should be ENCOURAGING [patients] to tell us what's going on and how these medicines are affecting their lives. I just think it's a missed opportunity."

Her statements were followed by immediate, spontaneous applause!

We have been told by our pharma marketing colleagues that the fear of lawsuits initiated by patients have prevented them from discussing adverse events in open forums. But it appears that the lawsuits pharma fears the most are NOT from disgruntled patients, but from disgruntled INVESTORS! That fear runs all the way up to the top of the organization; ie, the CEO, who is rewarded based upon stock price performance, not how well the company services patients.

Long gone are the days when a pharma CEO can truthfully say:

"We try to remember that medicine is for the patient. We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they will never fail to appear. The better we have remembered that, the larger they have been." -- George Merck - Founder of Merck & Co Inc.

Did J&J Troll Social Media Sites to Ensure Its Motrin "Recall" was a Secret?

A Blog is a very useful archive of information that over time may reveal connections between seemingly unrelated events. Take the Johnson and Johnson (JNJ) "phantom recall" of Motrin that I and many other bloggers have written about (see, for example, "Parallels Between BP and J and J" and "J and J ‘Phantom Recall’ Shows Motrin Troubles Go Back to 2008"). By now everyone in the US should know about this -- the story has been on the major news networks (see "Are Secret Drug Recalls Common?") and Ed Silverman has reviewed it admirably on Pharmalot (see "Johnson & Johnson Tap Dances Around Congress").

But when I was searching Pharma Marketing Blog for another story (ie, J&J's new scandal about the safety of the Ortho Evra birth control patch: "Did J and J Hide birth control patch risks?"), I came across a post about J&J Agents Trolling for Adverse Events on the Internet. In that post I recounted a story of a person who applied to be an agent for JNJ "where if chosen, [she] agreed to notify J and J if [she] became aware of any negative talk about their products" on the Internet.

At the time I wrote that post, I was mainly interested in how drug companies may be using social media to proactively learn about adverse events associated with their products in general. The fact that JNJ was doing this suggested to me at the time that the company was doing the right thing to ensure that it kept informed about any adverse events reported by patients.

The person ("Christine B.") who was contacted by BzzAgent about being a JNJ Internet/social media trolling agent posted her story to the Arthritis Foundation Forum, where she is a member (see the post here).

I immediately connected the dots: arthritis ... pain ... Motrin! Bingo!

The timing is right -- the post was made on Tuesday, September 22, 2009. JNJ's agents began secretly buying up Motrin in stores in the Spring of 2009. It's logical that "Christine B." and other people/patients who may frequent pain-related online forums was contacted soon afterward to see if the story had "leaked out" to the patient community.

JNJ contends that it did not intend to deceive the FDA or the public. However, if it was employing agents to ensure that its "phantom recall" was under the radar of patients who take pain pills, then JNJ may indeed intend to deceive the public, if not the FDA.

Of course, this is not a smoking gun, but perhaps the House Oversight and Government Reform committee should look into this and see if it can find evidence. The first place to look should be emails between BzzAgent and JNJ.

BTW, I suggest BzzAgent rebrand itself. "Agent" is beginning to take on some negative connotations!

How NOT to Solicit Adverse Medical Event Reports

My Twitter and real-life pal Fabio Gratton (@skypen) -- Co-founder & Chief Innovation Officer of Ignite Health -- sent out this tweet today:

New Web Site Invites Patients To Report on Adverse Medical Events: http://bit.ly/bp7EGx #fdasm #hcsm

Where Fabio tweets, I follow!

So I clicked on the link and found this article:

The Empowered Patient Coalition and Consumers Union's Safe Patient Project have launched a Web site that invites patients to fill out a 40-question survey about their experiences with an adverse medical event, Modern Healthcare reports.

The survey asks respondents to provide details on the incident, such as:

* The state where the error occurred;
* The type of health care provider involved;
* The procedure or treatment associated with the incident;
* Factors contributing to the error;
* Whether the affected patient considered legal action; and
* How the health care provider responded to the incident.

Patients have the option of submitting the survey anonymously.

The coalition said it plans to aggregate the information and use it to identify patterns that could lead to adverse medical events.

At first, I thought this survey was the one developed by Dr. Basch mentioned in my previous post: "If Patients Know Best, then Patient Social Networks Can Help Capture and Report AEs". Not the case. The article linked to this Empowered Patient Coalition web page.

I wanted to fill out the survey, but it quickly dawned on me that I had better things to do with my life than to wade through a Survey Monkey survey consisting of 43 (not 40) questions, many of them open ended.

This survey is no easier than the FDA's MedWatch Voluntary Reporting Form.

I don't see very many patients filling out the Empowered Patient Coalition form, which is too bad because I believe in the Coalition's cause: "We want the public to know that they can and must be the cornerstone to improving health care quality and safety and that their experiences are being counted. Sharing your story will ensure that your experiences will assist us in collecting data to be used to identify the sources of medical harm and to look for ways to keep patients safe in the future."

As far as "sharing stories" goes, patients are already doing that on sites like PatientsLikeMe, which can be mined for adverse events as I discussed here.

If Patients Know Best, then Patient Social Networks Can Help Capture and Report AEs

A recent article published in the New York Times caught my attention. The article -- "In Reporting Symptoms, Don’t Patients Know Best?" (find it here) -- suggested that doctors tend to "downgrade symptoms" (ie, adverse effects of drugs) reported to them by their patients because of "wishful thinking" or, worse, because they do not want to document problems they failed to act on for fear of being sued.

That being the case, there is little hope that widespread use of electronic medical records will capture useful adverse events that the FDA can analyze. Garbage in, garbage out as they say.

Speaking of garbage, the article criticized FDA's MedWatch program that allows doctors and patients to report problems that they think are adverse events from drugs already on the market. "But it’s a passive system that waits for reports instead of actively surveying patients," says the article. "Many people don’t know about it, and it has failed to catch some important adverse events," said Dr. Ethan Basch, an oncologist who treats men with prostate cancer and does research at Memorial Sloan-Kettering Cancer Center in New York.

"A better approach," says Basch, "would be to have large numbers of patients filling out questionnaires before and after drugs are marketed. For example, in the postmarket setting we could ask 5,000 selected patients starting Bextra to report monthly."

Of course, Bextra has been taken off the market by the FDA. Dr. Bach's point is that if post marketing surveys of patients were done soon after Bextra entered the market, the problems may have been noticed much earlier.

Meanwhile, Dr. Basch is working on his idea: "Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events" is National Cancer Institute funded outcomes Research project that began in October 2008 (see here). As part of that research, Dr. Basch and his co-investigators initiated development of an electronic patient-reported system for monitoring and reporting symptomatic AEs that patients may experience during treatment.

I imagine that this system would be pretty expensive to implement on a large scale across many different drug treatments. But there is a cheap (ie, FREE) electronic system already available for capturing adverse events from patients: patient-focused social media sites such as PatientsLikeMe (PLM) and others.

PLM found that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (an identifiable patient, a specific medication, an identifiable reporter and a reaction). This is 35 times the rate in the frequently cited Nielson study, which found only one such message in its random sample of 500 posts. (See "PatientsLikeMe Reports High Rate of Adverse Event Reporting Among Its Members".)

I'm not sure how Dr. Basch is getting his questionnaire out to patients, but he might look to social media sites like PatientsLikeMe to perform a public service and place the form on its site so that patients can easily access it. Just a thought on how social media can help expedite outcomes research!

NOTE: I will be speaking on this topic next week at the World Drug Safety Congress. The title of my presentation is "Web based AE reporting; is it the future?" I will specifically address how social media can be incorporated into a drug’s safety strategy and the challenges involved. If you have any solutions, ideas, or comments I can incorporate into my presentation, please tell me about them (you can email me at editor@news.pharma-mkting.com).