Monday, December 31, 2012

Some Interesting Pharma Predictions for 2013

It's appropriate that I present a few pharma industry predictions for 2013 in the last post of the year to Pharma Marketing Blog. To compile the following list, I used data from surveys, looked at the past year as an indication of what may be important in 2013, and reviewed predictions from  the usual suspects (e.g., people in the #pharma100 list).

It's also a good time to revisit a survey I started a couple of years ago that attempted to predict future healthcare market scenarios that would impact the drug industry. The survey asks respondents how likely it is for certain events or conditions to unfold in the next 5 to 8 years (ie, 2012 to 2019). You can see some results of that survey and my comments here.

So, here are my predictions for 2013, in no particular order. I invite you to provide feedback in comments to this post or in the surveys mentioned.

1. Direct-to-Consumer (DTC) Spending Will Continue to Decline

In the Predicting the Future of the Drug Industry: 2012 and Beyond survey, I asked respondents if broadcast (i.e., TV) Direct-to-Consumer (DTC) drug promotion will be banned or sharply curtailed by law in the U.S. This may have been a big issue back in the day, but it doesn't seem to be center stage right now. Less than 10% of survey respondents thought this was very likely to happen before 2019; it certainly would not happen in the coming year when lawmakers have many other pressing issues to mull over and do nothing about.

The economy, however, will continue to have a negative impact on DTC advertising causing a slow death by a thousand cuts. There already is a declining trend in traditional (broadcast TV, radio, and print) DTC spending as evidenced by this chart, the last bar of which I projected based on Lipitor going off patent and Pfizer's subsequent abandonment of efforts to continue promoting it (see "Lipitor Holds Key to DTC Ad Spending in 2012" and "Pfizer Throws In the Lipitor Marketing Towel").


Although the downward trend in the past may have been due to pharma falling over the "patent cliff," that will not be the main factor impacting DTC in the future. I believe that the "fiscal cliff" will be a major factor in 2013 as ALL advertisers -- not just pharma -- cut back on advertising. And it doesn't matter if we go over that cliff or not. The economy still sucks and companies as well as consumers will cut back their spending.

An article in today's WSJ said "Even before the uncertainty in Washington, the ad business had been expecting a lackluster ad climate for 2013, thanks in part to concerns about the U.S. economy. Earlier this month, several ad holding companies, including WPP, downgraded their global and U.S. ad spending forecasts" (see "Fiscal Cliff Casts Shadow Over Madison Ave."). "The drop in consumer confidence is concerning," said Tony Pace, chief marketing officer at fast-food chain Subway.

You may think that pharma consumers are not prone to the same economic pressures as are consumers of other products, but you are wrong. Some of the key findings from a Rodale DTC Marketing study illustrate a trend that will result in decreased traditional DTC spending:
  • People actively look to reduce their medical costs > Fewer doctor visits (21% canceled/delayed appt.)
  • Switch to generic when available 
  • More engagement in social media
You can weigh in on this topic by taking my "Future of Rx DTC Ad Spending" survey, which asks "Regarding the trend in measured media (broadcast TV, radio, and print) DTC spending by pharma, what do you predict will be the level of spending in 2013-2016 compared to 2009-2012?". You can see a summary of de-identified results after taking the survey yourself.

2. FDA Will NOT Issue Significant Social Media Guidance for Pharma in 2013

I already made this prediction; see "My Prediction for 2013: No Social Media Guidance from FDA."

3. A U.S. Citizen Will Be Injured or Die Due to Counterfeit Cancer Medicine

In 2012, we saw many deaths due to one unregulated compounded medicine produced and sold in the U.S. But we may be in for a rude awakening when the market is flooded with a slew of fake cancer drugs. As reported in an article in today's WSJ "fake Avastin that surfaced in the U.S. this year grabbed headlines, but it was just one example of a growing problem in the pharmaceutical world: the rise of counterfeit cancer drugs.
"Fake versions of costly cancer medicines have appeared in increasing numbers in Asia and the Middle East in recent years and occasionally in Europe and the U.S. In 2011, cancer drugs ranked eighth among the top 10 types of drugs targeted by counterfeiters, according to the Pharmaceutical Security Institute, an industry-funded group; five years ago, they weren't on the list at all.

"Authorities have seized some of the fakes in warehouses or shipping containers before they reached patients. But other counterfeits have turned up in pharmacies and hospitals, in one case injuring 80 patients in Shanghai."
If you think U.S. citizens are better protected than Chinese citizens, then you are not putting two and two together. The supply chain for cancer drugs is probably as loosely regulated as is the supply chain for compounding drugs. Doctors in the U.S. can order these drugs direct from wholesalers who compete to sell them at the lowest price. Again, due to the poor economy, many doctors are also looking to save money and increase profits by ordering drugs from shady sources. Perhaps this year one doctor will inject a counterfeit drug into a patient who may die as a result. It will be hard to prove the cause of death because of the dismal tracking of health records in this country, so while my prediction may come true, we may never hear of it!


4. Pharma Will Step Up Its Mobile Optimization Efforts

The next BIG opportunity for targeted pharma marketing to patients and physicians is mobile apps on "smart phones." That's one of the predictions I asked for input on in my "Predicting the Future of the Drug Industry: 2012 and Beyond" survey, which I invite you to take here. Seventy-seven percent (77%) of respondents to date agree with this prediction.

Up until now, there have been only one or two Rx branded pharma mobile apps released in the U.S. (see here and here). There may be a few more such apps in 2013, but pharma will really step up its effort to create Web sites that are optimized for mobile use. This makes sense because (1) only about 9% of U.S. adults over the age of 18 (19% of the 45% of smartphone owners) "happen to have" apps that help them track or manage their health, and (2) Mobile Optimization Offers Better ROI Than Mobile Apps. Read more about that here.

It also makes sense because pharma is so far behind other industries with mobile optimization, the only direction it can go is "up."

5. We Will See the Rise of the "Pharma Sales Rep Cyborg" -- Part Human and Part Machine (i.e., iPad) -- Which Will Save the Pharmaceutical Sales Rep from Early Extinction

A majority of respondents to my "Predicting the Future of the Drug Industry: 2012 and Beyond" survey think it is very or somewhat likely that "the role of traditional sales representative will become obsolete" by 2020. I think the "role" of sales reps has already changed and will be changed further in 2013 due to one device: the Apple iPad!

Pharma companies will develop smarter interactive detail aids for their sales reps in 2013 (e.g.., see "What Pharma Can Learn from Dexter"). This will definitely change the role of the sales rep, but I'm not sure how it will change. Most likely, smarter detail aids will allow physicians to interact with the data while the sales rep focuses on establishing rapport and making the sales pitch. That would mean that sales reps may revert back to being less knowledgeable about biology, chemistry, data, etc. All the recent talk about the "new sales model" may be turned on its head when reps become more like "sales rep cyborgs" -- part human and part machine (iPad)!

I could attempt some other predictions, but I think I covered enough areas of interest to me and I hope my readers. But the long-term predictions in the "Predicting the Future of the Drug Industry: 2012 and Beyond" survey is still of interest to me and I urge you to weigh in on those.

Friday, December 28, 2012

My Prediction for 2013: No Social Media Guidance from FDA

A month ago, I wrote an "open letter" to Megan Clark Velez, MPH, Office of the FDA Commissioner, asking her for more transparency regarding "actions completed" towards issuing social media guidance  on or before July 9. 2014, in compliance with the FDA Safety and Innovation Act (FDASIA). In my letter, which I also sent via snail mail, I referred to this date as the "Social Media Guidance Cliff" (see FDA's "Social Media Guidance Cliff": An Open Letter to Megan Clark Velez).

I have not heard back from Ms. Velez in response to my letter.

As of today, the FDASIA-TRACK database/website, which is supposed to notify us of "Actions Completed" toward complying with FDASIA, the entry for social media guidance shows NO ACTION:


Some ad agency people are still hoping for action on this front BEFORE FDA reaches the "Social Media Guidance Cliff" (see this Pharmalot Op-Ed piece). For example, Brian Reid, author of the Op-Ed piece, suggests that like the guidance for responding to unsolicited requests for off-label information (see here), FDA will include tidbits of social media guidance hidden away in OTHER guidance documents. "The first possibility is that the FDA develops a giant, comprehensive guidance document that drops sometime before the deadline, capturing the agency’s thinking on everything from online video to how you shoehorn risk information into a tweet," said Reid.

But, in light of recent court cases putting FDA in a defensive position regarding its off-label "rules" (see here), the off-label guidance FDA recently issued must be considered an outlier meant to shore up its defense (also, that guidance was not even included in FDA's 2012 "Guidance Agenda"). That is, you cannot assume the off-label guidance is a harbinger of how FDA will address social media in the future.

Just like Congress is dealing with the "fiscal cliff," I predict FDA will go down to the "social media guidance cliff" wire, with no solution in sight in 2013.

Although FDA Commissioner, Dr. Margaret A. Hamburg, launched FDA’s Transparency Initiative in June 2009, the agency hasn't been very transparent regarding social media guidance. While FDA representatives go to industry conferences and say things like issuing social media guidance is a "high priority," they do not commit to any specific dates. The 2013 "Guidance Agenda," for example, is nowhere to be found and, as noted above, FDASIA-TRACK does not list one single "action" completed that moves FDA forward in issuing this guidance.

For those experts -- like Mr. Reid -- who believe FDA may face the wrath of Congress if they do not meet the FDASIA deadline of July 9, 2014, I can only say you must be kidding! Congress has much bigger fish to fry with FDA (like compounding pharmacies). Perhaps, however, social media may be mentioned (in passing) as part of a "comprehensive" Congress-FDA "fish fry."

Thursday, December 27, 2012

Nominate Me (@Pharmaguy) for #Pharma100

My Twitter pal Henry Gazay, CEO, Medimix International, is at it again. He's compiling the #pharma100 crowdsourced list of the top100 Social media pharma "influencers."

It's "not a list of pioneers [I maintain that list here], not a list of pharma companies, not a list of pharma gurus, not a list of digital experts," says Gazay. Perhaps it's a list of pharma "aficionados" (see here)?

Last year, I was number 2 on the list (see here). This year, I also hope to make the list.

The rule is simple:

Between December 25th 2012 and December 31st 2012, you have a week to nominate who you consider to be among the top 100 influencers in Pharmaceutical Social Media.

To do so, just post on twitter "I nominate @xxxx for #pharma100 top100 influencers in #pharma social media".

TO NOMINATE ME, POST THIS ON TWITTER: I nominate @pharmaguy for #pharma100 top100 influencers in #pharma social media

You can nominate as many people as you want, but not yourself.

The count will be tallied on symplur, you can have a look at it here.

Friday, December 21, 2012

Happy Holidays from Professor Syrum: Bah. Humbug!

Thanks to everyone wishing me "Happy Holidays," including "Professor Syrum" from Boehringer Ingelheim's Syrum Facebook game. The good Prof sent me this e-mail holiday card:


The card links to the "Honey Badger Prequel" video on the "Beta Syrum" YouTube Channel. As of today, this video has 51 views -- I am in rarefied company indeed!


The video depicts a Christmas Past ("Christmas 1990") where Professor Syrum -- who sounds a lot like the evil emperor in Star Wars -- gives his young nephew Randall an animal picture book that includes Prof Syrum's favorite: the "Honey Badger."

Syrum is a multichannel endeavor, which obviously involves a lot of time and expense. To what purpose? you might ask. We don't know.

In any case, the campaign ultimately fails for me and every other U.S. citizen: I was contacted via e-mail (I signed up to be a beta tester), which linked to a YouTube channel, which linked to the game on Facebook. Unfortunately, when I clicked on the last link, I got an error message: "Use of app 'Syrum' has been restricted. Error while loading page from Syrum." Since I cannot play the game, the reference to the honey badger and "prequel" in the video are completely lost to me. Which is why I say "Bah. Humbug!"

Maybe by the time Christmas Future rolls around I may be able to finally play Syrum and "save the health of the world."

Meanwhile, Happy Holidays to Professor Syrum, BI, and all my readers and Twitter followers!

Wednesday, December 19, 2012

Can Obesity Be Treated with Cheap Antibiotics?

The authors of a scientific statement published in the American Heart Association (AHA) journal, Circulation, cited an analysis of the Framingham Heart Study, which found that "spouses, siblings, and friends were at greater risk for obesity if their "alters" (persons connected to the study subject who may influence the behavior of the subject) were obese" and that this effect was felt several circles out (see here).

Here's a diagram of a social network of people in the Framingham Heart Study published in a NEJM article (here). It's a cool diagram that is supposed to demonstrate, I believe, the connection between obesity and social connections (click on image for larger view):


Based on this evidence that social connections may spread obesity, the AHA authors describe social network-based interventions and recommend social media as part of a strategy for the treatment and prevention of obesity.

But there may be another explanation for the social connections found in the Framingham study: obesity may be caused by bacteria, which can be spread from person to person.

Yes, there is evidence that "obesity in human beings could be caused by bacterial infection rather than eating too much, exercising too little or genetics, according to a groundbreaking study," reports the Financial Times (here).

Take that, Mayor Bloomberg!

Dr David Weinkove, lecturer in biological sciences at Durham University (UK), said: "If obesity is caused by bacteria, it could be infectious and picked up from some unknown environmental factor, or a parent. It might not be behavioural after all."

Holy Smokes Batman! 

As the Financial Times points out, this "could have profound implications for public health systems, the pharmaceutical industry and food manufacturers."

The research linking bacteria to obesity was done in Shanghai, China where researchers identified a human bacteria "linked with obesity, fed it to mice and compared their weight gain with rodents without the bacteria. The latter did not become obese despite being fed a high-fat diet and being prevented from exercising."

If this is true, what could be the implications for the pharmaceutical industry? Will it be a boom or a bust? The drug industry is currently seeking a magic pill to treat obesity. They are studying complex, expensive molecules that focus on metabolism, not on simple, cheap antibiotics.

All this reminds me of the discovery that Helicobacter pylori causes ulcers. Ulcers can be basically cured with a combination of antacid and antibacterial drugs. According to wikipedia: The Helicobacter pylori bacterium was identified in 1982 by Barry Marshall and Robin Warren, who found that it was present in patients with chronic gastritis and gastric ulcers, conditions that were not previously believed to have a microbial cause. It is also linked to the development of duodenal ulcers and stomach cancer. However, over 80 percent of individuals infected with the bacterium are asymptomatic and it has been postulated that it may play an important role in the natural stomach ecology.

Tuesday, December 18, 2012

The Deadly Combination of Mental Condition, Guns and Rx Drugs

As we learn more about the young man who killed 20 grade school children and 6 adults in Newtown, CT, a few issues have been discussed in the news accounts: (1) he had access to an arsenal of weapons that would be the envy of a Syrian rebel commander, (2) he was trained in how to use those weapons, and (3) he may have been taking medication for the treatment of Aspergers.

While I am told that Aspergers is NOT a mental illness, it certainly is a mental condition/syndrome that may be treated off-label with powerful drugs that "may improve specific symptoms — such as anxiety, depression or hyperactivity — that can occur in many children with Asperger's syndrome" (Mayo Clinic).

It seems that many other young men who go on a sudden killing rampage have also suffered from mental conditions/syndromes and may have been under some kind of medical care. But we hear very little about how that care (not the syndrome or condition) could have been a factor in causing the rampage.

A quick search of the Internet on "Aspergers drugs side effects" can inform you that kids with Aspergers are "often treated with antidepressant drugs such as fluoxetine (Prozac®, Sarafem®)." According to "My Aspergers Child" blog:

"It is important for parents to work closely with the youngster's health care provider and to fully understand how to monitor the youngster for side effects of antidepressant medication. In some kids and teenagers, these medications may increase suicidal thoughts and actions.

"Other side effects that should be reported to the youngster's health care provider immediately include the following:
  • Aggressive or impulsive behavior
  • Agitation or restlessness
  • Increased activity level
  • Increased chattiness
  • Increased depression or anxiety
  • Increased irritability
  • Panic attacks
  • Sleep difficulties
  • Strange moods or behavior changes"
Perhaps the Newtown mass murderer was taking an antidepressant that increased his "suicidal thoughts." Knowing what we know about the shooter's mother, she pulled her son from school to "home school" him in isolation of support groups in the community that may have helped him. She may have also taken him OFF his medication, which may have resulted in increased "aggressive" behavior due to withdrawal effects.

There is ample evidence and warnings from the FDA that certain antidepressants can increase suicidal behavior in teenagers. So medication -- or lack of medication -- may have been a factor in this and other similar cases. Especially if the medication is prescribed off-label by GPs with little or no experience with mental illness. Pharma companies have pushed these inexperienced physicians to prescribe drugs that should only be prescribed by mental health experts, IMHO.

There is a connection between this line of inquiry and pharma marketing. I just alluded to drug companies marketing anti-psychotic and antidepressants to GPs. Direct-to-Consumer (DTC) advertising also is a factor in the increased use of these medications, but also helps explain why we don't hear more debate about the role of Rx drugs in murderous/suicidal ramages. Most of the news we have access to -- such as the nightly news programs -- are funded to a large extent by drug company ads. While these news sources go on and on speculating about increasing the regulation of gun ownership, none that I know of speaks of closer regulation of anti-psychotic and anti-depressant drugs. There is, however, more focus on mental health in general, but most of the focus is on mental health practitioners, not the drugs they may prescribe.

Neither mental conditions, prescription drugs, nor guns alone causes these tragedies, but the combination of the three greatly increases the odds of their occurrence.

Monday, December 17, 2012

Hey, Hey, the Internet saved my life today...

Have you seen this press release?

"Philips Survey Reveals One in 10 Americans Believe Online Health Information Saved Their Life"
A recent U.S. survey commissioned by Royal Philips Electronics (NYSE: PHG, AEX: PHIA), a leading health and well-being company, found that consumers believe web-enabled, mHealth and mobile apps are part of their health care solutions and key to living long lives. For example, one in 10 Americans (11 percent) surveyed believe that if it were not for web-based health information, “they might already be dead or severely incapacitated.”
Unbelievable!  I think you can find one in ten Americans who believe in anything you might suggest to them in a survey. That's got to be a rounding error.

Whatever! This factoid inspired me to rewrite the lyrics of the song "I Saved The World Today" (with apologies to Annie Lennox and the Eurythmics; listen to the original song in the YouTube video embedded at the end of this post):

Monday finds my symptoms like a bomb
That's been left ticking inside me too long,
Am I bleeding?

From my doctor, there's nothing left to learn
From him I get no e-mail in return,
I’m leaving.

Hey, Hey, the Internet saved my life today...
I’m happy now,
The bad disease has gone away.
And I’m happy now
The good drug's here to stay
Please let it stay.

There's a million mouths to feed
Pharma’s investors got everything they need,
Pharma’s breezing.

There was a hurting thing inside
And I've got side effects to hide.
But at least I’m breathing.

Hey, Hey, the Internet saved my life today...
I’m happy now,
The bad disease has gone away.
And I’m happy now
The good drug's here to stay
Please let it stay.

Saturday, December 15, 2012

Pharma: The Year 2012 in Images

These are my favorite images that appeared in Pharma Marketing Blog posts made in 2012. I think it's a good summary of the year in pharma marketing.

Friday, December 14, 2012

Pharma MLR "Social Media Scaredy Cats" Don't Trust Their SM Pioneer Employees

At the Social Media, Mobile & Gaming for Pharma conference in New York City this past Wednesday, a discussion about pharma being "committed" to social media took an interesting turn when an attendee "complained" that "every single word that we say -- every single word -- even the punctuation, has to be approved."

This person handles ALL the social media, including the Twitter account, for her (small) pharma company, which shall go unnamed.

Here's how she tweets: First she writes up a batch of tweets and submits them to her medical-legal-review (MLR) people for review and approval. This takes about a day -- lucky for her she works in a small company; a larger pharma company may take much longer to approve tweets.

What's sad is that this person wrote some tweets to be sent out during the conference she was attending, but she decided that her tweets were no longer relevant after she heard what was being discussed at the conference! Meanwhile, the things she would have liked to tweet about while at the conference, she simply could not tweet about without first getting approval!

This is no way to use social media. First of all, pre-tweeting comments that seem to be in response to a live event or online chat is not a good social media practice. What if someone responded to one of her tweets during the conference? How could she respond back; i.e., have a conversation?

When I heard this, I felt sorry for this pharma social media pioneer. "Your company doesn't trust you! How can you do social media if nobody trusts you?"

But the worst part is that this person feels she has a lot of leeway compared to other people she knows in the pharma industry.

Hey, I understand why pharma companies don't trust certain employees -- i.e., sales reps -- to use social media (see this case as an example). But if you have designated someone as the person to manage your social media communities, surely you have trained that person regarding your social media guidelines. What? You say you don't have no stinkin' social media guidelines? Well, then, shame on you!

In a world such as ours where a world-renowned bank that purposely laundered terrorist and drug trafficking funds can get away with a mere $1.6 billion fine and no jail time, then one single errant tweet made by a trained employee surely can be tolerated as a risk you can live with!

What's the worst that can happen, even if the FDA were to find out about the errant tweet (which I am sure they would not)? In the case of the sales rep mentioned above, the UK Prescription Medicines Code of Practice Authority (PMCPA) ruled that Allergan breached UK pharma's self-regulatory Code of Practice because an employee accidentally tweeted publicly about Botox. PMCA added "The Panel considered that Allergan had been badly let down by its employee." How sweet is that?

Anyway, I believe that many MLR people within pharma are "Social Media Scaredy Cats." It's probably a corporate "ladder" syndrome that goes all the way up to the CEO.

In contrast to the person whose was under the thumb of her MLR people viz-a-viz Twitter, there was someone from Boehringer-Ingelheim (BI) in the audience who did not seem afraid to live tweet. As you may know, I have had both good and bad things to say about BI's SM projects, but they are not scaredy cats -- as if my comments could scare anyone!

Thursday, December 13, 2012

Big Idea for 2013: Legalization of Marijuana. Will It Hurt Pharma?

According The Tennessean (see here), "Health officials believe that too many patients with dementia are being given antipsychotics in an 'off-label' use to control behavior instead of treating their dementia symptoms through non-pharmacologic therapy. Prescribing antipsychotics — approved by the FDA to treat schizophrenia and bipolar disorder among conditions — can expose a patient to medical risks."

I found this story interesting because of (1) recent news about the pharma industry promoting drugs off-label (see here), (2) the quest for an FDA-approved Alzheimer's drug that has so far failed to deliver (see here and here), and (3) a segment I saw on Comedy Central's Daily Show about the "Silver Tour," which demonstrates benefits of medical marijuana to old folks in nursing homes (see below).

The Daily Show with Jon StewartMon - Thurs 11p / 10c
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www.thedailyshow.com
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A Daily Finance article titled "Will National Legalized Marijuana Help or Hurt Big Pharma, Tobacco and Alcohol?" reiterated the "Silver Tour" claim that there are many medical conditions "where the ingestion of marijuana has been believed to help alleviate or control the symptoms. These include glaucoma, multiple sclerosis, AIDS-related complications, Crohn's disease, fibromyalgia, chemotherapy complications and others." You can also add Alzheimer's Disease and depression to that list. Since many of these conditions are common in the elderly, senior citizens may benefit the most from the legalization of marijuana.

Pharma companies, however, are very actively pursuing drugs for the treatment of the most common maladies of senior citizens. This may be why Pfizer, for example, created its "Getting Old" campaign (see here).

"The last thing [pharma] companies want see is current product lines that are producing dependable revenue flow to be dented by legal marijuana," says Lee Jackson, author of the Daily Finance article cited above. "The big pharmaceutical firms have a lot of money to spread around, so when it comes to lobbying efforts, very few have this group's clout. One thing it wants is for marijuana to remain illegal."

Aside from the medical need, another reason why legalizing marijuana makes sense: the "war" against it has failed.

Sir Richard Branson, founder and chairman of Virgin Group and member of the Global Commission on Drug Policy, says about the "war" on drugs, "let’s make 2013 the year we Break The Taboo."

"If a business strategy were failing and instead of curbing a problem made it worse, would you keep it going or would you stop and consider an alternative course? Strangely, the trillion dollar war on drugs has persisted for 40 years even though it is the most dismal global policy failure of our time" (video below).



What's you opinion regarding the legalization of marijuana?

Wednesday, December 12, 2012

Cautionary Tale About a Web-Based Tool Gone Awry

I just returned from the Social Media, Mobile & Gaming for Pharma conference in New York City where I participated in a panel discussion focusing on the future of social, mobile, & gaming within the pharma industry. I was joined by Julie Wittes Schlack, Communispace Corporation, and Heather Guidone, Center for Endometrosis.

We discussed a number of issues including my "pet peeve," which is health web and mobile apps that use a formula or algorithm to generate a number to help a physician make a diagnosis. One example of such an app is Janssen's "Psoriasis" app for the iPhone and iPad. This app includes a "PASI calculator." PASI stands for "Psoriasis Area and Severity Index," which is a tool for the measurement of severity of psoriasis.

The problem with this app is that there is no documentation that tells the physician the source of the algorithm. Also, there is no guarantee that the algorithm was programmed correctly without any "bugs." You can read more about this here: "Some Unregulated Physician Smartphone Apps May Be Buggy."

Imagine my surprise upon opening up my email just now to find a press release from The JAMA Network titled "Cautionary Findings in Study of Web-Based Tool for Children with Flu-Like Illness" (here)!

Here are some excerpts from the press release:
"While parents and caregivers reported that a web-based triage tool for children with influenza-like illness was easy to understand and use, the tool’s underlying mathematical formula needs to be improved so it does not result in more, rather than fewer, children seeking emergency department care, according to a study published Online First by Archives of Pediatrics & Adolescent Medicine, a JAMA Network publication. The study is being published early because its public health importance."

"Emergency department (ED) crowding is an issue, especially when demand for ED care is high, such as during an influenza epidemic. One potential strategy is to develop automated algorithms so patients can self-triage to determine if they need to visit the ED, according to the study background."

"Rebecca Anhang Price, Ph.D., of the RAND Corporation, Arlington, Va., and colleagues conducted a pilot validation study during the 2012 influenza season to get feedback on the Strategy for Off-site Rapid Triage (SORT) for Kids, a web-based tool intended to triage patients affected by the flu."

"An adult version of the triage tool was made available to the public during the 2009 influenza pandemic, but the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP), which jointly devised the pediatric algorithm, would not endorse the effort to make such a tool available for pediatric patients without evidence of its safety [my emphasis].
Although this concerned a Web-based algorithm, it could have just as easily been developed as a mobile app, which leads me to ask the question: Where is the "evidence" that mobile pharma apps such as the PASI calculator is safe, in the sense that it can lead to false positive diagnoses and over prescribing? But safety aside, should these apps be certified as accurate? Shouldn't they cite references for the source of the algorithms used?

These are just a few of the questions I am asking readers to give me feedback on in my Regulation of Pharma Mobile Medical Apps Survey. Please take 5 minutes to respond to this survey. When you complete the survey, you'll be able to see a de-identified summary of results to date. Thanks.

Tuesday, December 11, 2012

Decline in Online Drug Advertising Leads to 14% Downsizing at WebMD

There is no better bellwether for the state of online pharma advertising than the health of WebMD, a leading website that depends on health industry -- mostly pharma -- advertising.

In a press release, WebMD announced today "a comprehensive program to streamline its operations, reduce costs and better focus its resources on increasing user engagement, improving customer satisfaction and driving innovation." By "streamline," WebMD means laying off 250 employees, about 14% of the company's workforce.

According to Tech Crunch:
"During its most recent quarterly results, the company saw revenue decline from $135 million during the year ago period to $117 million, with sponsorship and advertising income especially taking a downward turn. WebMD reported a net loss of $900K on the quarter, compared to positive income of $14.2 million during the same quarter last year. Still, its site traffic continues to grow, according to its quarterly financials, with 22 and 24 percent increases for unique visitors per month and page views between Q3 2011 and Q3 2012. So what’s behind the losses and the resulting need for budget cuts? Despite a growing audience, it seems like advertisers are either less interested or less able to create campaigns on WebMD."
Back in January, I noted (here) that the Wall Street Journal reported that WebMD's Chief Executive Wayne T. Gattinella resigned, and the health-website operator "called off a search for a buyer as it braces for weaker financial results this year. A key issue, the company said, is pharmaceutical companies holding back on spending as they deal with expiring drug patents." (see "Dip in Drug Ad Spending Leads to WebMD Woes").

It appears that a significant portion of WebMD's woes is due to one product going off patent: LIPITOR. As I predicted, Lipitor (or lack thereof) Holds Key to DTC Ad Spending in 2012 (see here).

P.S. I was interviewed by a reporter at MarketPlace.org for the following segment that aired on December 11, 2012:

Monday, December 10, 2012

Magic vs. Marketing: Not as Different as You May Think!

Dennis Urbaniak (@DUrbaniak), VP U.S. Diabetes at sanofi-aventis, winner of the 3rd Annual Pharmaguy Social Media Pioneer Award (see here), tweeted a link to a blog post titled "Avoiding Magic for Magicians, Marketing for Marketers" by Christopher Penn, the author of Marketing White Belt. Clearly, Mr. Penn is outside my limited universe of the pharmaceutical industry, so I thank Dennis for bringing this post to my attention.

In his post, Penn says there are two types of magicians: those who perform tricks to impress other magicians and those who perform tricks to entertain an audience of ordinary people.
"If you get trapped inside the magician’s fishbowl," says Penn, "your magic changes to be more about deceiving other magicians, magicians who already know the majority of the basic tricks. Your tricks get increasingly complicated and complex, and as a result, more entertaining to magicians who understand the different levels of skill needed to perform the tricks. Paradoxically, your tricks get less and less entertaining to the general public, who can’t tell the difference between an Olram subtlety and a monkey shuffling cards."
Penn relates this to what some marketers, including pharma marketers, may be doing:
"What does this have to do with marketing? The same fishbowl can sneak up on you as a marketer. Read enough marketing blogs or SEO blogs or hang out at enough social media conferences and you risk starting to play marketing magic to other marketers and not the general public. Anyone who’s been around an SEO person who’s had too much Kool-Aid has seen this – their ability to use the English language itself changes when they spend all their time using every trick they’ve found."
Penn's advice for overcoming this: "You’ll find that a handful of basic techniques performed flawlessly with great showmanship will win you audiences on the magic stage, and a handful of basic marketing techniques performed flawlessly with great content and stories will win you business."

Essentially, avoid the hype around the new shiny thing (e.g.. big data, multichannel, segmentation, etc.), and get down to basics: storytelling.

That's good advice for marketers in general, but maybe not so good advice for pharma marketers, who find it difficult to include brands in their "storytelling" without putting the audience to sleep or scaring them with the required side effect information.

Maybe that's why many pharma marketers -- including Dennis Urbaniak and his diabetes group -- prefer to do "unbranded" marketing such as disease awareness campaigns like "Diabetes Co-Stars" (listen to this podcast: "Diabetes Co-stars Casting Call Contest").

Being successful, however, at "winning business" through unbranded storytelling might require some pharma marketing tricks (see book jacket & disclaimer) designed to deceive other pharma magicians/marketers who are working the same audience.

Sunday, December 09, 2012

When It Comes to "Low T" Treatment, Which Does Your Gut Trust: Axiron or Androgel 1.62%?

My blogger friend, Rich Myer over at World of DTC Marketing, thinks that "Lilly got the Axiron site wrong" (see here). "Lilly’s site for Axiron is not user friendly and probably scares more men away than driving them to ask for an Rx," says Rich. According to Rich, there is just too many warning messages on the site: "The homepage... looks more like a warning to stay away from the product."

In case you didn't know, Axiron is approved for the treatment of low testosterone; i.e., Primary hypogonadism and Hypogonadotropic hypogonadism. Or, as marketers like to call it, "Low T," which is much less scary than "Hypogonadotropic hypogonadism." Heck, almost any guy over the age of 50 can have Low T (more about that below)!

Axiron (and also competitor Androgel 1.62%) contains testosterone, a "Schedule III controlled substance," which means it is in a category of drugs considered to have a "potential for abuse or addiction." Both Axiron and Androgel have "black box" warnings as part of their labels:


It used to be that a "black box" meant that the drug would not be advertised directly to consumers (DTC) on TV at least because to mention the dire black box warnings would warn people to stay away from the drug, just like Rich says is happening on the Axiron site.

But these are real drugs for real men (OK, maybe would-be "real men") who want to get it on real fast and who don't give a damn about side effects they may cause in other people that come into contact with them. Such side effects of secondary exposure include "virilization" (i.e., women looking like men, acne in women, unexpected signs of puberty in children). Men using these drugs can experience this unmanly direct side effect: "azoospermia" or lack of sperm.

Some pretty serious stuff. It seems to me, therefore, that Lilly's Axiron site does a proper job of calling attention to these problems.

But why focus only on Axiron? What about Androgel?  Is the Androgel website much better than the Axiron website? Here's a graphic showing the homepages of both sites:


In case you can't tell them apart, Axiron is on the top and Androgel is on the bottom :-). The level of scare is the same for both because both have the same black box warning as part of the FDA-approved label and both have serious side effects.

There is one important difference between these sites: Axiron takes a less aggressive marketing approach than does Androgel. While both sites extol consumers to "talk to their physicians," only Androgel includes one of those phoney-baloney "symptom quizzes" that are designed to make every male over 50 believe he has Low T. I've criticized such quizzes before (see "OMG! Do I Have ED or 'Low T?' Or Both?! Pharma "Symptom Quizzes" Are NOT in the Best Interest of Patient Health!").

Here's how I answered the Androgel quiz:


Abbott Labs, which markets Androgel, says" "If you answered 'yes' to questions 1 or 7 or at least three of the other questions, your symptoms may be caused by Low Testosterone. Hit your back button and print out this completed quiz and bring it to your doctor to discuss Low Testosterone." I guess I might have Low T after all :-(

Like Comedy Central's Stephen Colbert, I too want to protect myself from becoming "gullible," which scientists say is another symptom of old age that perhaps Androgel can fix. If I take Androgel, however, I might become less gullible. But being less gullible means I may no longer believe the marketing hype, in which case I will be in danger of becoming just another "non-adherent" patient that Abbott Labs will soon forget -- new Rx's are key, after all.

Survey Reports Mislead About Pharma Use of & Spend on Social Media

PharmExecBlog summed up Cegedim’s "2012 US Pharma Insights" survey this way: "while more pharma companies are using social media and mobile platforms to enhance their sales and marketing initiatives, budgets did not reflect an increase in social media spend" (see Companies Trim Social Media Spending, While Platform Priorities Shift). Andrew Spong "rescooped" this under the headline "Pharma employee use of social platforms up by 36 percent in 2012."

Once again, we are fed data about pharmaceutical companies that (1) have very little basis in reality, and (2) are not specific to traditional pharmaceutical companies that manufacture and market prescription small molecule and biologics.

The title of Cegidim's survey and white paper summary ("2012 US Pharma Insights") is itself  misleading because the majority of respondents are NOT employed by  traditional pharmaceutical companies. Only 40% of respondents of Cegedim's survey describe their company’s principal line of business as prescription small molecule and biologics. The next biggest "line of business" is "other":


All the results of this survey that are summarized in a Cegidim white paper reflect the total responses, including the 60% of respondents who are NOT employed by traditional pharma companies; i.e., generic companies (which do very little marketing), consultants, ad agencies, and "other."

Regarding social media use and spending, the white paper includes these two charts:


How can you interpret these results to say anything that reflects the actual situation with regard to traditional pharma companies? Perhaps 90% of the 50% who said that social media spending by their companies was less than 5% are employed by traditional pharma companies. Perhaps 90% of the 42% who said their companies use social media for Public Relations and only 20% of the 64% who said their companies use social media for marketing are employed by traditional pharma companies. Or maybe it's vice versa. Who knows?

Unless we can see the data specifically from the 40% of respondents who are employed by traditional pharma companies, we cannot make any conclusions about how to apply these data to traditional pharma companies.

As for (1), although I am not an expert in statistics, I suspect that the N in this survey was much less than 1,000 because Cegidim claims that "percentages are subject to a 6.709 point margin of error and were tested for significance at the 90% confidence level." To me, that sounds like N=200, more or less.

I'll contact Cegidim to see if I can get only the results of this survey from the 40% of pharma respondents and report back here. I only wish that PharmExec, Andrew Spong, and the dozens of other people reporting these results as "pharma" data would have done that for me.

UPDATE: I received a response from a Cegidim spokesperson in my voicemail box: "I do not have an analysis of the segment you are looking at, just an analysis of the entire universe."

Friday, December 07, 2012

Speaking of Sanofi: A Blog for Pharma Aficionados

"Dear friends, employees, and pharma aficionados..."

That's how Stacy Burch, Director, Corporate Reputation and Digital Communications, at Sanofi US, began the first post to her company's new blog Speaking of Sanofi (read "Speaking of Blogs..."; here ).

"pharma aficionado" - I like the sound of that, so I created a new fake magazine with that as the title. The cover of the first issue is shown on the left.

According to Google -- which now offers definitions when you search on words like "aficionado" -- the word "aficionado" means "A person who is very knowledgeable and enthusiastic about an activity, subject, or pastime." Synonyms, according to Google, include "fan - devotee - lover."

Perhaps "fan - devotee - lover" is a bridge too far for me, but I am certainly somewhat knowledgeable and enthusiastic about the pharmaceutical industry, at least to the extent that I will read and make comments to blogs like Speaking of Sanofi.

I remember the good old days when a pharmaceutical blog was a big deal. Now, however, it is quite common. Of course, blogs about specific pharmaceutical products are rare because the industry still doesn't want to talk about their products in "open" forums such as blogs.

Speaking of Sanofi is not really an open forum -- to submit a comment, you must first register, then sign in, then decode a captcha (very tough!)... And then your comment goes into a moderation queue.

I understand the need for comment moderation -- I have moderated comments submitted to this blog for many years. But I have discovered that registration, captchas, and moderation are significant road blocks for discussions on blogs. Therefore, I have turned all that off on this blog.

Luckily, I am not a regulated pharma company. I'm just a "pharma aficionado," free to relax with a fine imported pill and devote a lot of time learning more about the drug industry.

Many Smartphone Apps Lack Privacy Policies

"California's attorney general filed a first-ever privacy lawsuit against the maker of a smartphone application, a move that could shape how the nascent app industry handles personal information," reports the Wall Street Journal (here). The case involves the Delta Airlines Fly Delta app, which allows customers to check in to flights, pay for checked baggage and perform other tasks related to flying.

I have noted previously that many of the pharma health apps I have reviewed do not include privacy policies (see, for example, "Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story"). In fact, some pharma companies may be among the 100 companies that California's attorney general, Kamala D. Harris, sent letters to in October, giving them 30 days to respond or make their privacy policies accessible in their apps.

"While California is unique in applying its privacy law to apps," said the WSJ article, "Ms. Harris has said she hopes to use the state's influence in the technology industry to benefit users nationally." The article notes that "even as privacy policies on websites have become commonplace, many of the most-downloaded mobile apps don't have them."

In my Regulation of Pharma Mobile Medical Apps Survey, I ask respondents whether or not they agree with this statement (among others):
"If an app collects personal information, it should include a privacy policy that explains how such data is protected (security), who owns the data, how users can access the data, where data is stored (on device or on remote web site) and instructions for opting out of data collection."
The survey also asks opinions regarding the FDA regulation of pharma apps, self-regulation by the industry, third-party certification, testing of algorithms, etc.

I won't reveal the results until I collect more responses -- you can view a de-identified summary of the results after taking the survey yourself (click here). Thanks for your input.

Thursday, December 06, 2012

Are Today's Social Media Sites Helpful in Managing Chronic Diseases Like Diabetes?

In an "Open letter to NPR about Diabetes Social Media piece," Kerri Morrone Sparling of Six Until Me, attempts to refute a claim made by Jason Bronner, a doctor at the University of California San Diego Medical Center, who said "There's no proof in diabetes that social networking is helpful."

Sparling, receives free products from two drug companies, and one pays her to speak at events and contribute at her site. In her disclosure statement Sparling says she is "employed by, run disclosed advertisements from, or consult with dLife, diaTribe, Incendia Health, Agamatrix, DexCom, BetterHealth LLC, Johnson & Johnson, LifeScan, Novo Nordisk, Children with Diabetes, Roche, The Juvenile Diabetes Research Foundation, Animas Corp, WEGO Health, and CVS."

Such disclosures, however, are not enough for Jeff Chester of the Center for Digital Democracy, who says people don't read disclosures and that "pharmaceutical companies are using social media to promote their gadgets and drugs in a deceptive way." Chester, as you might recall, was a guest on my Pharma Marketing Talk Show (listen to the podcast: "New Media Tracking Technologies - Implications for Online Consumer Privacy").

Disclosures aside, I want to get back to the question of whether or not today's social media sites are "helpful" in diabetes (or any other chronic disease) and the stake that pharma companies have in promoting social media for diabetes.

Dr. Bronner obviously has a stake in proving whether or not SM helps patients. His study was featured in a segment of a local San Diego NBC affiliate news program, which concluded with a statement from Dr. Bronner's group that said "social networks outside [my emphasis] the Internet do improve chronic disease management":

View more videos at: http://nbcsandiego.com.


Sparling says "initial evidence suggests that the benefits of social media to people living with chronic illness are real, even though large scale studies have not shown precisely who benefits and how much" and
"Dr. Bronner’s study leaves out one of the most important benefits that is consistently mentioned by people with diabetes online: connecting with others. When they connect, they no longer feel alone, and they receive much needed emotional support to help them go through the ups and downs of life with this chronic condition. And some of the end result measurements of health outcomes in diabetes, such as HbA1C, fail to capture all the preliminary steps necessary to achieve the behavior changes that result in improved, quantifiable outcomes."
OK. What we have here is a failure to communicate. On the one hand, there's the physician who's looking for "evidence" that diabetes is being managed. That involves numbers such as Hba1C.

On the other hand is the patient argument that "emotional support" is also a key benefit.

One could argue that BOTH sides have merit, but if HbA1c levels in type 1 diabetics are are not brought to normal levels, then the disease is not being "managed" no matter how much "emotional" support the patient receives from social media.

Dr. Bronner's study also aims to determine if social media can help diabetics "improve their knowledge skills and attitudes about their condition." Sparling's addresses the latter, but fails to say anything at all about the former; i.e., improving knowledge about diabetes.

I notice that there are a few dozen signers of Sparling's "open letter." Most of these are members of the "diabetes advocates" organization; i.e., people with diabetes. There is at least one pharma person who has also signed the letter and urged others to do so by (re)tweeting about it: Dennis Urbaniak (@Durbaniak).

Urbaniak, who is VP U.S. Diabetes at sanofi-aventis, was also quoted in the NPR piece about what his company has learned from type 1 diabetics on social media:
"In the past, the ads would always show the perfect blood sugar number, and the community says, 'You know, that's a bit insulting because it implies it is always easy to get this. Show a number that's high or show a number that's low. Make it real.' And so this is the kind of feedback that's been really helpful."
Sanofi must also have learned that knowledge and education are also important social media deliverables for people with diabetes. That is why they launched "Diabetapedia," the goal of which is "to help meet educational needs of diabetes community." According to Laura Kolodjeski, Community Manager, Sanofi US diabetes, the overarching goal is to create "a single, comprehensive place where anyone can find and share definitions of diabetes-related terms and phrases" (listen to this podcast: "Diabetapedia: 'Google' for Diabetes").

Dr. Bronner's study is focused on one closed (by invitation only) social media community. If he was to look at Diabetapedia, I am sure he would find there is a lot more the site can do to "improve the knowledge skills" of people who use the site. Meanwhile, I have been running a little survey (here) to determine how sanofi can improve the usefulness of its Diabetapedia web site. Here is some preliminary results of that survey in a chart:


Social Media as it was Way Back When
Maybe some of these ideas will soon be implemented on Diabetapedia, but right now pharma-sponsored social media sites like this do not even equal the knowledge improvement skills that were available via Internet support groups as long ago as 1996. In support of that, I'll give you one example based on my own experience with "DIABETES-EHLB," an email-based discussion group for people with diabetes, diabetes educators, caregivers, and endocrinologists (for more background, read "Pharma 'Social Networks': Close But No Cigar Award"). It was sponsored by Hoechst Marion Roussel, a pharma company that later merged with other companies that eventually formed Sanofi-Aventis (funny how me and sanofi and its its predecessors have had relations going back to 1994; NOTE: I currently am NOT paid by sanofi or any of its agents and I do not run ads from pharma companies, unless they are Google adwords).

Contrary to Urbaniak's experience, members of DIABETES-EHLB often discussed "numbers" like HbA1c for managing their disease. Here's an example of a web archive page found on the "way back machine:"


Responses included detailed information about HbA1c tests copied from government sites like the National Institutes of Health, highlights of presentations at an annual ADA conference, and advice for where to have the test done by mail. If you are interested in seeing these responses, click here (pdf).

As opposed to this, here's what Diabetapedia says about A1c:



I am impressed mostly by the emptiness of the page, which may reflect sanofi's lack of interest in "numbers." I assume that non-pharma diabetes social media sites offer better "knowledge skill" building than this.

Diabetapedia may not be the best example of what sanofi is doing in concert with the diabetes online community (DOC). You might want to check out "Dennis Urbaniak, Joan Mikardos, and Laura Kolodjeski of Sanofi US Receive the 3rd PharmaGuy Social Media Pioneer Award."

Sanofi is also pioneering in their use of "real patient stories" through its "Diabetes Co-stars Casting Call" contest, which is soliciting video submissions from patients. To learn more about this, listen to this podcast: "Sanofi US to Develop Documentary Featuring Real Patients and Their Stories."

Tuesday, December 04, 2012

What's at Stake in the Off-Label Promotion Debate: It's NOT Free Speech!

In case you haven't heard, in a 2-to-1 split decision, the 2nd U.S. Circuit Court of Appeals in New York on Monday threw out the conviction of a sales representative for promoting off-label use of a prescription drug (see story here).

The majority decision written by Circuit Judge Denny Chin -- the same judge that rejected Google’s deal to digitize books (see here) -- was based on last year's Supreme Court ruling that "Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment." According to Judge Chin, the "pharmaceutical representative's promotion of an FDA-approved drug's off-label use is speech" and he was prosecuted "precisely" because of his "speech in aid of pharmaceutical marketing." Ergo, "we VACATE the judgment of conviction and REMAND the case to the district court."

There's enough legal issues in this case to keep a ship-load of constitutional and pharma lawyers busy for years. But I'd like to look at this from a different perspective -- i.e., what pharma has to gain from this and what patients have to lose.

This particular case involves several off-label discussions between a sales rep and a physician who recorded the conversations. The drug being promoted by the sales rep was Xyrem, a powerful central nervous system depressant, approved for "narcolepsy patients who experience cataplexy" and "narcolepsy patients with excessive daytime sleepiness." Xyrem's active ingredient is gamma-hydroxybutryate ("GHB"). GHB has been federally classified as the "date rape drug" for its use in the commission of sexual assaults. Xyrem can cause serious side effects and, if abused, it can cause additional medical problems, including seizures, dependence, severe withdrawal, coma, and death. It's FDA labeling includes a "black-box" warning.

To promote this drug off-label, say for use in children under the age of 16, or for "restless leg syndrome" (which can be diagnosed without any evidence other than what the patient testifies to), might be considered by any sane person a danger to public health, akin to yelling FIRE! in a crowded theater when there is no fire.

But that is exactly what the sales rep did. On October 26, 2005, Caronia (the sales rep defendant in the case) "plainly promoted the use of Xyrem in unapproved indications with Charno (a physician who recorded the conversation as an agent for the FDA):
[Caronia]: And right now the indication is for narcolepsy with cataplexy . . . excessive daytime . . . and fragmented sleep, but because of the properties that . . . it has it's going to insomnia, Fibromyalgia[,] periodic leg movement, restless leg, ahh also looking at ahh Parkinson's and . . . other sleep disorders are underway such as MS. 
[Charno]: Okay, so then so then it could be used for muscle disorders and chronic pain and . . . 
[Caronia]: Right. 
[Charno]: . . . and daytime fatigue and excessive sleepiness and stuff like that? 
[Caronia]: Absolutely. Absolutely. Ahh with the Fibromyalgia."
On separate occasions, Caronia and Gleason (the physician paid by the drug company) each explained to prospective physician-customers that Xyrem could be used with patients under age sixteen, an unapproved Xyrem subpopulation:
[Caronia]: Um, the youngest patients we have are sixteen in the studies as old as sixty-five. Ahh there have been reports of patients as young as fourteen using it and obviously greater than sixty-five. It's a very safe drug.

[Gleason]: Well, it's actually approved for sixteen and above um, I've had people under thirteen and I've certainly talked to neurologists that have narcoleptics . . . between eight and ten . . . [but] I start at two-thirds the dose, but [if] they're real frail I only start with one-third the dose.
Other than quoting the above conversation,  Judge Denny Chin did not consider the safety of patients as part of his reasoning for reversing the lower court's decision. And neither did the drug industry, which filed a "friends of the court" brief (see "Drug Firms Push to End Ban on Off-Label Marketing").

Judge Chin only only conceded that "While some off-label information could certainly be misleading or unhelpful, this case does not involve false or misleading promotion [my emphasis]. Moreover, in the fields of medicine and public health, 'where information can save lives,' it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed."

That kind of thinking supposes that all information is helpful, whereas we know that a lot of information promulgated by many marketers, including pharmaceutical marketers, can be unsupported by evidence; i.e., some "information" can be "carefully wrought bullshit" (see here).

Even the "evidence" that pharma companies use to "prove" the efficacy and safety of drugs is being questioned (see "The Case Against EBM"). But I rather not get into that here.

In her dissenting opinion, Circuit Judge Debra Ann Livingston was more focused on the safety issue: "one way in which a drug is misbranded is if its labeling lacks adequate directions for layperson use." She points out that the FDA defines “adequate directions for use” as “directions under which the layman can use a drug safely and for the purposes for which it is intended."

"But some uses of drugs are never safe, at least for a layperson," said Judge Livingston, "because it is impossible to provide adequate directions for such uses, this provision also effectively prohibits introducing drugs into interstate commerce with the intent that the drugs be used in ways that are unsafe for laypersons... the simple fact that one is generally allowed to sell something does not imbue one with a constitutional right to sell it for any intended purpose. And the prohibition here on distributing drugs with the intent that they be used for purposes not supported by their labeling is entirely consistent with the broader purposes of the FDCA -- namely, minimizing those occasions on which patients use drugs that have not been shown to be safe and effective."

Drug companies would save a bundle of money if they did not have to prove to the FDA's satisfaction that a drug is effective for every medical condition for which they have a shred of evidence. In this case, Caronia did not even mention specific evidence, but merely inferred that his company was "looking at" uses of Xyrem in the treatment of MS, Fibromyalgia, Parkinson's, whatever! I pity the patients whose physicians take this "carefully wrought bullshit" as evidence and prescribe a drug as dangerous as Xyrem for off-label indications.

Saturday, December 01, 2012

Google's NEW Rx Drug Search Results Page Raises Question: Will It Spur New, Favorable FDA Guidelines?

Last year I posted data that showed Google's OneBox Rx "Ads" steal clicks from organic branded Rx search results (see chart below).



I just learned that Google has gone one step further. Instead of a small adword-type box near the top of the search results page (i.e., BELOW the paid ad, if any), there is a large box on the upper right-hand portion of the page that includes a lot more information. The following screen shot illustrates the size and placement of the new "sidebar" drug information box on the search results page for Lipitor (click the figure for an enlarged view).



Here's how this version (right) compares with the "old" OneBox version (left):



Google says "this data comes from the U.S. FDA, the National Library of Medicine, and the Department of Veterans Affairs, among others" (see here).

Lacks Lifestyle Information
Aside from the difference in size and page location, these two versions have one extremely notable (IMHO) difference; i.e., the old version includes the phrase "used along with diet, exercise, and weight loss" whereas the new version does NOT include any lifestyle info, which FDA and PhRMA recommend to be included in direct-to-consumer (DTC) ads on TV and in print (see DTC Guideline #12) .

The source of the information in both versions is said to be the National Library of Medicine (NLM), which has this description of Atorvastatin:
"Atorvastatin is used along with diet, exercise, and weight loss to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Atorvastatin is also used to decrease the amount of cholesterol (a fat-like substance) and other fatty substances in the blood. Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body (see here)."
Why is the lifestyle information missing in the new version of Rx search results? Why has Google decided to switch to this new version in the first place?

As you know, I have a conspiracy theory that involves Google and those infamous 14 NOV letters concerning search ads FDA sent to pharma companies in 2009 (see here). According to that theory, FDA is forcing Google to implement these Rx information boxes because it was a "bad boy" by encouraging illegal drugstore paid ads to be included on search pages. FDA "punished" Google with the 14 letters, cutting off lucrative drug company advertising. The result of this was the "OneBox",  2010 version, which competed with drug company search engine referrals as noted above. My thinking is that drug companies complained to the FDA and Google about this and that resulted in the 2nd generation, 2012 version of the Rx information box devised by Google.

The new box, however, is much bigger and more visible than the old version. This could not have been acceptable to the drug industry without further concessions such as (1) eliminating the lifestyle information, which PhRMA guidelines only suggest for TV and print ads anyway, and (2) making the info box look LESS like a competing paid search ad and moving it out of the area typically reserved for paid and organic search results.

It is unknown whether of not the new format will alleviate the problem of competition with organic and paid search ads illustrated in the chart at the beginning of this post. I'd be interested in hearing more opinions about that and seeing some data.

Will It Spur New, Favorable FDA Guidelines?
If indeed FDA, Google, and Pharma are collaborating on what information to include in the box and and where it should be located on the Rx search result page, then we may be closer than we think to FDA coming out with new favorable guidance for drug industry search ads; e.g., officially sanctioning this "beta" version of Rx adwords shown below:


That would be the best concession pharma could hope for.
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