Mark Senak over at Eye On FDA Blog has analyzed 235 Warning Letters (WLs) and Notice of Violation (NOVs) letters issued by FDA's Office of Pharmaceutical Drug Promotion (OPDP) since 2005. He cataloged 600 violations, including:
risk omission or minimization,
superiority claims,
overstatement of efficacy,
unsubstantiated claims and
broadening of indication
When Senak specifically looked at letters regarding pharma marketing videos (excluding TV DTC ad videos), he found that 80% of the violations concerned risk minimization (40%) or overstatement of efficacy (40%). Below is the remake of his pie chart of these data (for the original data see "Viewing Video’s Regulatory Profile").
What's interesting is that these videos -- mostly patient and physician testimonials -- overstate efficacy at TWICE the average for all kinds of promotions (40% for videos vs. 21% for all ads, including video). Senak postulates that "when people talk about their own experiences with a treatment, [they] may include reference to outcomes that is not typical or supported by clinical data."
An example of a video that overstated efficacy was a video testimonial featuring Ty Pennington posted on youtube.com by Shire. FDA said "Both the webpage and video overstate the efficacy of Adderall XR; the video also omits important information regarding the risks associated with Adderall XR use."
Dr. Michael Anderson, a pediatrician for many poor families in Cherokee County, north of Atlanta, routinely prescribes Adderall to kids who get poor grades in school. To do that, he first must commit fraud: submit a false diagnosis of attention deficit/hyperactivity disorder (ADHD) to Medicaid and/or private insurer.
The doctor admitted his fraudulent activity in a story published in today's New York Times (here). “I don’t have a whole lot of choice,” said Dr. Anderson. “We’ve decided as a society that it’s too expensive to modify the kid’s environment. So we have to modify the kid.”
He does this believing in his heart of hearts that ADHD is “made up.” His excuse? To prescribe the pills to treat what he considers the children’s true ill — poor academic performance in inadequate schools.
Dr. Anderson’s instinct, he said, is that of a “social justice thinker” who is “evening the scales a little bit.” He said that the children he sees with academic problems are essentially “mismatched with their environment” — square pegs chafing the round holes of public education. Because their families can rarely afford behavior-based therapies like tutoring and family counseling, he said, medication becomes the most reliable and pragmatic way to redirect the student toward success.
This is wrong on so many levels. For one thing, who made Dr. Anderson and other physicians who feel the same way judge and jury regarding what school is "adequate" or "inadequate"?
That, of course is not the main problem, which is prescribing a dangerous, additive drug to children who have no real medical need. This is clearly a case where a drug's benefit does not justify the risks that the patients are subject to. "Reported side effects of the drugs have included growth suppression, increased blood pressure and, in rare cases, psychotic episodes," says the NY Times.
Not mentioned by the Times is the dangers of addiction. ABC News recently ran a story documenting this problem: Dangers of Adderall Addiction Among Moms (see here or view the embedded video below).
If moms can become addicted to Adderall, their children can also become addicted. When they can no longer get Adderall, they will try other drugs easily available from physicians or on the street (see, for example,
This is so egregious that I must ask if Dr. Anderson has received payments from Shire Pharmaceuticals, which sells Adderall XR (the extended release version of Adderall, which Shire sold to Teva Pharmaceuticals). Unfortunately, Shire does not publicly disclose such payments. According to its compliance Web site (here), Shire only reports spending on HCPs (healthcare providers) to a "limited number of states as required by the individual state laws."
Adult ADHD (attention deficit/hyperactivity disorder) is the "next big thing" for pharma companies like Shire, which markets Vyvanse for the treatment of ADHD in adults. So says the author of a Salon article titled "Big Pharma’s newest invention: Adult ADHD."
“Immature adult market continues to offer greatest commercial potential,” read a 2008 press release to the pharmaceutical industry from the market research agency Datamonitor: “Estimated to be twice the size of the pediatric ADHD population, the highly prevalent, yet largely untapped, adult ADHD population continues to represent an attractive niche to target.”
So who might consider themselves part of this “untapped” market?
Well, former Philadelphia Phillies center fielder Shane Victorino for one. The "Flyin' Hawaiian" is now an adult ADHD celebrity spokesperson appearing in magazine ads like the one shown below and in video testimonials like the one you can find on ShanesStory.com.
If you talk to people in the know, Victorino is an ideal adult ADHD "poster boy." I've heard that Victorino was a mile-a-minute talker and often people around him wished he'd shut up. In a Shire-sponsored YouTube video, Victorino himself admits "always interrupting" his teammates and having problems focusing.
Interestingly, Victorino doesn't mention Vyvanse. It's unclear, therefore, if he benefited from Shire's drug, which entered the market in 2007, about 8 years into Victorino's major league career and about the time that Victorino became a starting player for the Phillies.
So it's unclear if Vyvanse -- or any other medication -- helped Victorino play ball as well as he did for the Phillies. Some have speculated, however, that his constant talking and interruption of teammates was one reason why the Phillies traded him. Could the trade be part of a devious Phillies plot to insert a disruption agent within the ranks of a rival team?
I'm just kidding, of course. Like many Phillies fans, I like Victorino and wish hime the best.
Unlike some other pharma-paid celebrities, Victorino is not promoting a brand of drug, but promoting awareness of a medical condition. Some people -- like the Salon article author -- claim that ADHD awareness marketing is a form of "disease mongering," which causes more people to be diagnosed with the condition than is necessary. But that's a whole other issue that I don't have time to get into now. You can read about disease mongering here.
Imagine my surprise when I read this in today's Wall Street Journal: "Akili Interactive Labs Inc. of Boston, formed by start-up-creating firm PureTech Ventures, and San Francisco company Brain Plasticity Inc. are seeking Food and Drug Administration approval for a video game treatment they hope clinicians will turn to before prescribing medicines for ADHD" (read the story here).
I've been writing a lot about "gamification" and the pharma industry (see "Pharma & Fun, Not Oxymoronic? Here Comes Gamification!" and "Gamification, Then and Now", for example), but never from the perspective of games designed to compete with drugs such as Novartis' Ritalin, a stimulate indicated for the treatment of ADHD.
Akili -- meaning "wisdom" in Swahili -- is the name of the video game that Akili Interactive Labs hopes will be the first ever video game "treatment" approved by the FDA. The game is designed to run on smartphones and iPads. The company also hopes clinicians will recommend the game to patients before prescribing medicines for ADHD.
Fat chance!
First, fat chance that the FDA will actually approve a video game as an effective treatment for a medical condition. Second, fat chance that even if approved, health insurers/patients will pay for a game treatment after being conditioned all these years to think only of drugs as treatments. Third, fat chance that physicians will prescribe the game to their patients. That would require overturning the entire drug-physician industrial complex!
Nevertheless, Akili co-founder Eddie Martucci said "his company's research shows that people want choices other than today's powerful medicines. 'We would aim to have efficacy and tolerability that outstrips any of the drugs.'"
Wow! Are these guys anti-drug industry? NOPE! Senior Partner, Chairman of PureTech Ventures is Dr. Ben Shapiro who was previously Executive Vice President, Worldwide Licensing and External Research for Merck. Another Senior Partner at PureTech is Dr. John LaMattina, who was previously President, Pfizer Global Research and Development and Senior Vice President, at Pfizer Inc.
LaMattina, who also writes the Drug Truths Blog at Forbes, was once enthusiastic about torcetrapib, a drug that Pfizer hoped would replace LIPITOR. "We believe this is the most important new development in cardiovascular medicine in years," said LaMittina. That was before Pfizer halted development of torcetrapib and after it spent more than $800 million on its development (read "torcetrapib: $800 Million Failure but Kindler Safe"). Hopefully, Akili isn't costing nearly as much to develop as a new drug.
With such experienced drug industry veterans as partners, Akili might have a chance of making it to the FDA. Unless, of course, clinical trials reveal dangerous side effects.
It's not likely such side effects will be similar to those that torcetrapib caused; i.e., death. Some video game critics, however, fear that "electronic media might improve visual attention but impair the ability to sustain attention on a hard or boring task," notes the WSJ article. "The latter type is what teachers need from students, according to ... Douglas A. Gentile, a developmental psychologist at Iowa State University." What teachers DON'T need, however, is for students to claim that playing video games during school is part of their medical treatment!
It's interesting to speculate how FDA-approved video games would be marketed, assuming any will actually be approved by the FDA. Akili, for example, might splurge on exhibits at medical meetings and lure physicians into its booth to play the game. And maybe it would hire physicians to be "consultants" and "speakers" to promote the game to their peers. I'm betting that direct-to-consumer (DTC) TV ads would be out of the question -- much too expensive for a product unlikely to reach "blockbuster" levels of sales.
I do, however, envision that DTC social media could be very cost-effective for marketing FDA-approved video game treatments.
In 2009, he famously "quit" his position at Merck to become a YouTube comedy star on the basis of the popularity of his fart videos (see "Was Nalty's Fart Video the Straw that Broke Merck's Back or was it Some Other Video?"). He now is back in the pharma fold as Consumer Product Director, Psychiatry Consumer Marketing, at Janssen, a division of Johnson and Johnson.
According to his LinkedIn profile: "Kevin Nalts is the only career marketer who doubles as one of YouTube's most-viewed entertainers. He is formerly an innovation leader at Johnson & Johnson, and product director at Merck. Author of 'Beyond Viral' (Wiley & Sons), Nalty helps companies and causes engage customers in the most visceral form of social media: online video."
It's interesting that Nalty is now able to be open about his "Nalts" YouTube alter ego while employed at a major pharmaceutical company. Since "Nalts" suffers from attention deficit hyperactivity disorder (ADHD), he is probably involved in the marketing of CONCERTA, Janssen's drug for the treatment of ADHD in adults and children. Will Nalty be able to bring some humor into the ADHD field as in his "ADHD Boy" video shown below? Time will tell.
NOTE: The ADHD Boy video includes Adword links to advertising sponsors, one of which is CONCERTA! See if you too can spot the ad, which looks like this:
The add link, www.focusonadhd.com, goes directly to the CONCERTA site (www.concerta.net NOT www.concerta.com).
NOTE: See comments to this post by "Nalts," who explains he is NOT involved in the marketing of CONCERTA. In fact, he claims his ADHD was probably a "misdiagnosis." In any case, he shut down the ads for ADHD Boy to avoid any semblance of conflict of interest. Also, in the opening graphic, the phrase "Not taking drugs is like not drinking water when you are thirsty" is a direct quote from one of Nalts' tongue-in-cheek videos, which may or may not still be available on YouTube. In other words, it's just another "Naltyism" that should not be taken seriously -- much like marketing :-)
Now that Nalty is once again a pharmaceutical company employee, I have added his @Nalts Twitter account to my list of Pharma Twitter Pioneers (see here). Because of his "Farting in Public" YouTube video (here), which to date has garnered close to 13 million views, @Nalts has over 13,000 Twitter followers. This eclipses the number of followers of @Alex__Butler, another Janssen (UK) marketer!
A couple of pharmaceutical companies have already taken down their Facebook pages or announced they will do so. These include Janssen's ADHD Moms page, which was the first pharma Facebook page, launched in June, 2008, by McNeil Pediatrics (see The Pharmaguy Social Media Timeline™).
"A new Facebook policy, scheduled for Aug. 15, will specifically impact communities that are formed to help people learn more about disease conditions, such as ADHD Moms™, which we sponsor," says a note on the ADHD Moms page.
"This new policy will alter our ability to consider the appropriateness of comments before they are posted which is important to us as a company in a highly regulated industry."
"As a result, our ADHD Moms%reg; community will not be available after Aug. 14. Additionally, as of Aug. 9, our Moments™ tab will no longer be available. We want you to know that we value the community formed on this page and this was a difficult decision, but necessary given the Facebook policy change. We apologize to anyone in our community who may be disappointed by this decision."
"Please note that we will be discontinuing the sanofi-aventis VOICES page, effective August 9. We would like to continue this conversation with you, so we ask that you go to the Sanofi US Facebook page to do so."
This marks a turning point in pharma social media. Janssen effectively abandoned 23,725 (more or less) people (including 28 0f my Facebook friends) who "liked" ADHD Moms. It offered no alternative to these people other than third-party resources. Sanofi-Aventis, on the other hand, directed its 859 friends (including 22 of my friends) to its Sanofi US Facebook page, which currently is liked by 360 people (including 11 of my friends).
On the Sanofi US Facebook page, the company states that "To comply with applicable Laws and regulations, we do not use the standard Facebook wall for discussion." It does, however, allow comments on a special "Discussions" page where it previewsthem before being posted. "Just a friendly reminder that all posts are being moderated to ensure they comply with our Terms of Use," said Sanofi.
I had problems finding the Terms of USe, so I posted a question asking where I could find them. I received a reply within 2.5 hours (see screen shot below). The time stamp is odd - I actually posted my question around 3 or 4 PM Eastern US, but the time stamp says 2:20 AM; perhaps my Twitter pal @jonmrich can explain this discrepancy. Another thing Jon might be able to explain is how come Sanofi can still have comments shut off on its wall?
Did the new Facebook policy actually cause these companies to shut down their pages? Janssen seems to put all the blame on Facebook whereas Sanofi seems to blame "Laws and regulations," implying government interference. Of course, there are NO federal Laws or regulations specifically prohibiting Sanofi or any other pharma company from using the "standard" Facebook wall for discussions.
Blaming Facebook or "Laws and regulations" for this reminds me of the final scene of King Kong where the beast is lying dead at the foot of the Empire State Building:
Police Lieutenant: Well, Denham, the airplanes got him. Carl Denham: Oh no, it wasn't the airplanes. It was beauty killed the beast.
I think there are other reasons why these pages are being shut down -- (1) one (ie, ADHD Moms) may have outlived its usefulness, and (2) one (VOICES) may have been ill-conceived in the first place, giving no benefit to the company and having a tainted history. In these cases, it's just best to shut them down and move on.
Unfortunately, Janssen doesn't seem to have an alternative FB page. It just "abandoned" its 23,725 FB friends. In the scheme of things, this is not a big number considering that Janssen claims ADHD "impacts five million children in the United States, while nearly eight million adults have been diagnosed with the condition" (see here). 23,725 represents only 0.47% of the children's ADHD market. In other words, ADHD Moms was a dismal failure in terms of reaching this market - maybe.
Over the next few days I will maintain a vigil over the pharma Facebook death march. Help me by letting me know of other pharma Facebook pages that announce their demise.
I, and others, have often criticized pharms's forays into social media as being "inauthentic" because no real dialogue is allowed (see, for example, "Pharma "Social Networks": Close But No Cigar Award"). Without the dialogue, social media campaigns are not likely to reach full potential by "going viral," which is the point recently made by my Twitter friend @jonmrich during an #hcsmeu discussion last Friday. "Here's a hint for pharma," said Jon, "Nothing will go viral if you don't allow 'Likes' or comments. Guaranteed."
There are, however, a few pharma social media sites that DO allow comments and Johnson & Johnson (JNJ) leads the pack in that regard.
Today, I discovered (hat tip to @andrewspong) that Janssen-Cilag, Ltd, part of the Johnson & Johnson family of companies, is probably the first European pharmaceutical company to produce a non-branded disease awareness YouTube video that allows comments and "Likes." The video is entitled "ADHD: A day in the life by Janssen-Cilag Ltd." You can view the video here or see embedded version at end of this post. But just in case it is pulled in the future, here's a screen shot:
According to the channel notes "This new short film, produced by Janssen‐Cilag Ltd , tackles some of the issues surrounding Attention Deficit Hyperactivity Disorder (ADHD) from the perspective of a child with the condition. For more information visit www.livingwithadhd.co.uk.
"The film was made after talking to groups of doctors, patients, parents and teachers, who told us that too often people think 'ADHD' is just an excuse for 'badly behaved kids'. The film should help people understand what it's like to actually have ADHD.
"If you know anybody affected by ADHD, please do share this film with them. Together, let's make sure all families get the help and support they need."
The "Commenting Policy" states "All submissions will be reviewed and may not be posted if deemed inappropriate. Comments which are off-topic, offensive, or promotional, will not be posted. Please note that we will not post comments about any specific products or treatments, whether they are sold by Janssen-Cilag Ltd or not."
@garymonk, who apparently is the person responsible for this YouTube site, says that Janssen-Cilag has published the "vast majority" of comments. I believe it because there is "a couple of spats boiling away" according to @andrewspong, another Twitter friend of mine.
The site also allows visitors to vote whether or not they "Like" the video. As of today only 51 votes have be cast (43 like the video, 8 do not like it).
Will this video go viral? So far the video has been viewed 58, 624 times since it was uploaded on June 9, 2010.
It's interesting to note that the Johnson & Johnson (JNJ) YouTube video, "Brad's Story: A 12-year old with ADHD," is at the top of the list of related videos. It also allows comments and "Likes." The JNJ ADHD video was uploaded to YouTube back on June 22, 2009 and has been viewed 62,983 times (150 "Likes" vs 12 dislikes). So, by that measure, the Janssen-Cilag video is doing rather well. It should be pointed out that JNJ's YouTube Health Channel includes 302 videos. In all, the total upload views for JNJ's videos is 2,170,352.
JNJ Health Channel's Rob Halper, Director, Video Communication at Johnson & Johnson, is a "Friend" of Janssen-Cilag's Living with ADHD. "Great channel! Terrific contribution to You Tube," said Rob. BTW, Rob Halpert is one of the people nominated (by me) to receive the coveted Pharmaguy Social Media Pioneer Award (see the announcement below).
The Pharmaguy Social Media Pioneer Awards
We might be tempted to give Janssen-Cilag a reward for launching "ADHD: A day in the life" social networking campaign. But instead of having awards for specific pharma social media sites or campaigns, why not give awards to the pioneers who have lead the way? We can learn more from how these pioneers overcame the obstacles to launch social media projects or promote social media than from the end result – even if the end result is flawed. People tend to live much longer than their creations and pharma social media pioneers are no exception. They may move on to new positions and spread their influence far and wide.
Who is @garymonk, for example? I want to know more about this person. How did he get to be in charge of the Janssen-Cilag YouTube ADHD channel? What are the issues he had to deal with? Etc.
That is what the Pharmaguy Social Media Pioneer Award is all about. Let's discover the pioneers and hear their stories. Please use this online form to nominate candidates. The introduction explains the rules for nominating candidates and you can also vote on a dozen or so candidates that I have already chosen.
P.S. I found out who @garymonk is. He is Gary Monk, a Product Manager (Marketing) at Janssen Cilag and, according to his LinkedIn profile, he has already won a few awards such as: The "2009 PM Society Digital Awards - Triple Award Winner (1) Best overall promotional solution (2) Best Integrated Campaign (3) Best Edetail." Nevertheless, I added his name to the nominees for the Pharmaguy Social Media Pioneer Award.
