The Coming Pharma Digital Depression Caused by Facebook

P&G Discovers It's "Free" to Advertise on Facebook!

That's the gist of an article written by Jim Edwards over at Business Insider - Advertising (read the article here).

Of course, advertising on Facebook is not really free, but it's pretty darn close when compared to TV. According to the article, "P&G said it would lay off 1,600 staffers, including marketers, as part of a cost-cutting exercise."

Interestingly, P&G CEO Robert McDonald had some interesting comments about the cost-effectiveness of digital advertising, including:
"I believe that over time, we will see the increase in the cost of advertising moderate. There are just so many different media available today and we're quickly moving more and more of our businesses into digital. And in that space, there are lots of different avenues available. In the digital space, with things like Facebook and Google and others, we find that the return on investment of the advertising, when properly designed, when the big idea is there, can be much more efficient."
If a packaged goods company like P&G is "moderating" its cost of advertising by shifting to digital and laying off marketers, then the pharmaceutical industry can't be far behind. A "recession" in pharma digital marketing is even more likely considering the well-known "patent cliff" that's currently in progress; ie, blockbuster drugs with a combined $170 billion in annual sales will go off-patent by 2015. That means even less mass media advertising and more digital advertising.

But "more digital advertising" does not mean that much more money will be spent in the digital arena. That's because of social media, where it's virtually free to advertise!

Today, I will present a webinar on this topic as part of a BrightTalk "Digital Marketing & Pharma Summit" series of webcasts. The title of my presentation is "The Coming Pharma Patent Cliff and 'Recession' in Digital Spending."

According to BrightTalk's Quoc-Thai Dang, "At this summit, we'll be exploring the realities of how Pharma is spending it's budgets on digital. Experts will critically evaluate the impact of social media and mobile marketing, and if this has had an impact on their business."

My webinar will be at 10:00 AM this morning (January 31, 2012). You can go here to attend live or listen afterward or use the widget below.

I admit that my ideas are only half-baked and invite your comments.

Paula Deen & Victoza: Brilliant or Dumb?

OK. I've written so much about Novo Nordisk's deal with celebrity chef Paula Deen that even I am tempted to say "Enough already! Move one." Well, there is one side of this story that I and others have not yet commented on. That is, what do Novo's troops (ie, sales reps) have to say about it? Specifically, do they think this deal will help them sell Novo's type 2 diabetes drug Victoza -- the drug Deen is a spokesperson for? Or will it hurt sales?

To get answers to those questions, I turned to the Novo Nordisk company board on Cafe Pharma (CP) - the notorious but always entertaining and enlightening pharma sales rep message board. I learned about some other issues that the "troops" discussed, including:
  • Heredity vs. Lifestyle as contributing factor
  • Is drug treatment the first option recommended when diagnosed with type 2 diabetes?
  • The role of the American Diabetes Association (ADA)
  • Will Victoza be prescribed off-label for weight loss?
One anonymous commenter,  had this to say:
"This is either the most brilliant marketing strategy ever or the dumbest."
That, of course, remains to be seen.

It's Dumb!
Interestingly, this commenter added some further remarks that offers intriguing insight into the possible strategy of Novo Nordisk's entire diabetes franchise:
"Just think," said this anonymous sales rep, "Paula and her fat fans go from victoza to levemir to novolog. I give her 1 more year and she is on insulin." Not that this rep thinks this is an honorable strategy for Novo to support. "Novo should do the honorable thing here and cancel this deal. Defeat diabetes my ass. They have just done more to cause diabetes than mcd's [McDonald's]. It is like Marlborough Man being a spokesman for Nicorette. Shameful."
Of course, it's possible that this anonymous rep was a rep from a competing pharmaceutical company and not a Novo rep at all. In any case, other commenters had similar things to say, such as:
"Wow. This is a PR disaster. Who were the brains behind this fiasco? Victoza is taking major hits in the media with the whole world now focused on price ($500 a month!) and questions being raised about drug safety and marketing ethics. Novo just bought itself a few million dollars worth of bad publicity. Time to pull the plug to save face."
It's Brilliant!
There were also plenty of posts in defense of the deal:
"Granted, she is still in denial, but she's on Victoza, she's already lost a dress size since starting and it's a Dean family endorsement. Which is even better because it shows it does take a village to help patients with diabetes treat their disease. This is a horrible disease that is difficult to manage. Everyone is playing into Novo's hands with all the press around diabetes and becoming more aware. Novo couldn't pay for all the ads they've gotten over the past week."

"First of all, this whole flap will be short lived. It wont be long before it's been long forgotten. Secondly, PD's hardcore fans couldn't care less about how long she took to reveal her diabetes. If Paula takes Victoza, guess what those hardcore fans are going to ask their doctors to prescribe for them. And there's millions of them too. Most of the critics are selling Novo's management short. Time holds the answer as to what will happen, but my money is on the whole thing being wildly successful.

"the posters who think its ridiculous are the competitors bc they are mad their idiot companies didnt do this first. Its brilliant. Brilliant bc we all know the success rates with Victoza. Our docs rave about it all the time. Theyre not going to write more lantus bc PD was hired by Novo.

"This is brilliant. Do you think Weight Watchers cared when Barkely supposedly trashed their endorsement by saying it was easy money to eat their meals and lose weight? No, it was good TV. This will be for Novo, too. Welcome to big pharma."

From a marketing perspective, is the Novo Nordisk deal with Paula Deen Brilliant or Dumb?
It remains to be seen.

Someone else pointed out that drug treatment is not the only solution for people with Type 2 diabetes ("T2DM"):
"It is not a 'horrible disease' – it is a disease of gluttony and sedentary lifestyle. T2DM is reversible with implementing healthier eating habits and adding exercise to your daily routine. The alliance with Paula Deen (spelled D-E-E-N) suggests that people can continue to eat what they want and take a drug to make everything all better. Don’t try and spin this alliance as social responsibility – your intentions are purely economic in nature."
You'll Hear More About Heredity and Type 2 Diabetes
The lifestyle change solution POV will be something that Novo and Deen will have to combat as they get deeper into this. In fact, they have already pinpointed "heredity" as the most important factor. This was re-iterated in a comment in response to the above:
"Heredity? Have you ever heard of that? But, what do doctors know? After all, you're an anonymous CP poster, so you know it must only be about gluttony and a sedentary lifestyle. Pick up a textbook some time...you might actually learn something."
In response:
"When diagnosed with t2dm, what are the first instructions a doctor should give to their patients according to the ADA? The answer: diet and lifestyle changes. Why is that? Is the ADA wrong? Are doctors wrong for following the ADA guidelines? Why even bother with this step if heredity is such a controlling factor? Your message to people with diabetes suggests that they can't help themselves without the aid of your pharmaceuticals."
Will the ADA be Caught Up in This?
I'll have to check up on what the ADA has to say about first options. I already know that ADA is part of the deal because the organization has said the Deen family will participate in select diabetes health expos the ADA hosts around the country. It has also been reported that Deen will contribute some of her Novo earnings to the ADA, although no specific monetary amounts were mentioned.

Is Weight Loss a Possible Future Indication for Victoza?
One last point concerns weight loss and whether or not Paula Deen will help sell Victoza for that purpose. CP comments relating to that include:
"She will drop 40 lbs over the next year or less and "bang" we have an unofficial weight loss drug. (no indication necessary) Frankly I think its brilliant, she is probably under contract to eat healthier and exercise....and write a a cookbook with healthier versions of her food. We should look forward to seeing her at the next national POA. May I suggest identifying and adding the weight loss clinic docs in your area to your universe, otherwise you will not get paid Bad press now...millions of dollars later. Laughing all the way to Denmark."
Of course, if Novo or any Novo sales rep were caught mentioning weight loss as a indication, they would be breaking the law and subject the company to hefty fines, as this commenter pointed out:
"glad to hear all the weight loss drug talk. Can't wait to see Novo pay all those off label promotion fines"

Allergan "Badly Let Down" by Employee Tweet

The 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 (read the details here "Brits Versus Botox Tweet").

Basically, an employee sent a public tweet to a friend in which he/she mentioned Botox and said "... we could do something around stroke rehab..." That was considered advertising to the public, a no-no in the UK and the rest of the world outside the U.S.

But PMCPA showed compassion saying that it noted that Allergan had a policy that clearly stated "no Allergan employee might comment in a social media forum about Allergan products or business activity."

PMCA added "The Panel considered that Allergan had been badly let down by its employee."

I sure would like to see Allergan's "Global Social Media Policy." I wonder if it is similar to Pfizer's infamous "social media playbook?" (see here).

Maybe Elya Zarra, who is currently part of Legal Department - Regulatory Affairs/Compliance at Allergan would send me a copy. Part of her duties include "Development and implementation of internal policies and strategies, including a global social media policy" (see her LinkedIn profile). I can't send her a direct message through LinkedIn because she requires contact only through her LinkedIn friends. And she doesn't have a Twitter account that I can find. Perhaps it's against policy for her to have one.

Taking the "Cool" Way Out of Having Rx Product Convos on Social Media

I have criticized pharma companies for mentioning Rx brand product names via social media. Mostly because they forget to include fair balance or don't educate the public (see, for example, "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!").

That doesn't mean, however, that I don't believe there is a way for pharma to engage in branded product discussions via social media such as Twitter and Facebook (see, for example, "Breaking the 140-character Limit of Twitter Opens the Door to FDA-Compliant Branded Tweets").

It appears that most pharma companies have decided not to engage in these kinds of discussions and are implying that FDA regulations prevent them from doing so.

Take for example a discussion about Paula Deen on the Novo Nordisk Facebook wall (here) . Amidst the criticisms and defenses of Novo was this statement by "Tanya", a representative of Novo Nordisk:

"Hi Darcy, I had to remove your post becuase (sic) you mention a product name, which we are not allowed to have on our page - even if you post it yourself. Can you repost without mentioning the product name? Sorry! -- Tanya"

Unfortunately, I can't see what product was mentioned because the post was deleted. Duh! However, it was probably Victoza -- the diabetes product that pays for the endorsement by Paula Deen.

I infer from Tanya's statement that there is some FDA law or regulation against mentioning product names on the Novo FB page. In fact, there is no such law or regulation. And in other "social media" contexts -- such as my BlogTalkRadio show -- Ambre Morley, Associate Director, Product Communications, Novo Nordisk, didn't seem to have any problem mentioning the product name. In fact, she didn't point out the possible side effects (fair balance). I'm not sure if she broke the law there or not (you can read a summary of that discussion here; use code '1111nvd' to get it free; or listen to the podcast here).

Are pharmaceutical companies missing an opportunity to educate people about their products by "handling" posts as Novo did in the above example?

Some people actually think this policy of removing posts that mention products is a good thing. Idil Cakim, for example, said "the Novo Nordisk community manager 'played it cool' by only reminding the fans of the FDA guidelines" (see "Novo Nordisk Handles Paula Deen Reactions on Facebook").

I should have put a "sic" next to "FDA guidelines" because there are NONE! Tanya only reminded people what Novo Nordisk's POLICY is. [To be more clear, Tanya SHOULD have said "it is our policy not to mention product names."] I guess Idil -- one of "the world's best social media thinkers" featured on socialmediatoday.com -- also inferred from Tanya's statement that there was a LAW or guidelines.

There are, in fact, some new FDA guidelines for dealing with certain branded communications on social media (see "Review of The Social Media Guidelines Nobody Expected!"). These guidelines only apply to "off-label" discussions on social media sites. I don't know if these guidelines were applicable in this case.

Tanya may have "played it cool," but she missed an opportunity to really inform her FB visitors about Victoza, assuming that was the product mentioned in the deleted post.

But without more encompassing FDA social media guidelines, every pharma company will just continue to take the easy "cool" way out and censor any mention of product names on its social media sites.

P.S. Dear Novo Nordisk: Sorry that I seem to be focusing on you these past couple of weeks! But you ARE in the news a lot these days. I'm not sure it's helping or hurting the sales of Victoza because you don't mention the drug much in public statements about Paula Deen or on your Facebook page. That's fine. Just so you know. I'm not picking on you exclusively. I've gone on posting binges against Pfizer, Boehringer-Ingelheim, and practically every other pharma company. So, please don't take it personally.

Should Pharma Disclose Payments to Celebrity Spokespeople?

In my podcast interview of Ambre Morley (listen here or read it here: "Novo Nordisk Defends Choice of Paula Deen as Diabetes Spokesperson"), Associate Director, Product Communications, Novo Nordisk, I brought up the subject of compensation for celebrity pharma spokespeople like Paula Deen, the celebrity chef who was recently hired by Novo Nordisk as a diabetes spokesperson.

Obviously, Paula Deen is being paid to do the deed, but she doesn't want to talk about money because it's ‘garish’ according to her. But for me, talking about how much money is spent in the different areas of pharmaceutical marketing is a valid topic. I’d like to get a better idea how much money the drug industry spends on celebrity spokespeople. I always ask the money question because the industry is criticized for spending so much money on celebrities and it takes away from other things that the money can be spent on.

When I asked Morley the money question, she demurred and said “We don't discuss compensation. If Paula was a regular, everyday employee, I couldn't tell you how much she is making. I can't tell you how much I'm making nor would I ask you how you're making."
Aside: Deen must have felt the heat about her compensation. It was reported that "she announced that she and her sons will donate part of their compensation from Novo Nordisk to the American Diabetes Association, and an ADA spokesperson confirmed that the Deens will be appearing without pay at upcoming events. (see here)"
A few years ago, the pharma industry could have used the same excuse for not revealing how much they paid physicians as speakers, consultants, key opinion leaders, etc. But today there's the Physician Payment Sunshine Act, which requires that all pharmaceutical companies reveal details about the payments they make to physicians (see "Proposed Rules for Physician Payment Sunshine Act").

Of course, the main reason why this law was passed was because of potential conflicts of interest -- physicians who are paid by pharma companies may be more likely to prescribe the drugs of those companies. Often, those drugs are more expensive than other, equally-effective products (eg, generics). Congress has a fiduciary duty to make sure that the government doesn't overpay for services such as Medicare re-imbursements for prescription drugs. Consequently, the impetus for passing this law.

Celebrities, however, do not have the power to directly prescribe drugs. But they are VERY influential. Morley admits as much: "When you talk about the pharmaceutical industry and it's spend on celebrities, it's interesting because you wouldn't see celebrities working on campaigns if it wasn’t a good investment from a marketing point of view."

Given the power of of celebrities to influence people, should pharmaceutical pharmaceutical companies disclose the details of payments made to celebrities like like they are required to do for physician payments?

That's just one of the questions I ask for your opinion on in the following survey. I also ask:

  • Is it OK for pharmaceutical companies to pay celebrities to be spokespeople to raise awareness of medical conditions?
  • How about celebrities being paid to promote specific Rx treatments? Is that OK?
  • Do such celebrity spokespeople provide a good return on investment for pharmaceutical marketers? 
Please take a few minutes to respond to these questions in the following survey. At the end you will be able to view the de-identified summary of results to date.

Create your free online surveys with SurveyMonkey, the world's leading questionnaire tool.

Did FDA Entrap Google with Those 14 NOV Letters?

Con Artist Reveals All About Google Drug Ad Sting - How FDA May Have Entrapped Google Using Those 14 "Infamous" Notice of Violation Letters

In an interesting article in today's Wall Street Journal, a convicted con artist details how he was employed by federal agents -- including agents of the FDA's Office of Criminal Investigation -- to lead a sting operation against Google's illegal drug ad operation (see story here). Recall that last summer Google agreed to pay $500 million to settle DOJ charges that it helped illegal online pharmacies target ads through its AdWords platform. It was one of the largest forfeitures ever paid in the U.S. (see "Google Settles with DOJ - Admits Aiding Illegal Online Drug Sales").

"It was very obvious to Google that my website was not a licensed pharmacy," said David Whitaker, the prisoner who acted in the sting. "There was a part of me that felt bad," Mr. Whitaker wrote in his account of the undercover operation viewed by The Wall Street Journal. "I had grown to like these people." But, he said, "I took ease in knowing they.. knew it was wrong."

What is of interest to me is the timeline revealed in the WSJ article. I added a couple of events to this timeline shown below (click on the image to enlarge it for better readability).

Mr. Whitaker made first contact with Google in March 2009. On April 2, 2009, FDA made public those "infamous" 14 notice of violation (NOV) letters that effectively shut down Rx drug search advertising on Google. In October 2009, comScore data was released that documented this "prompt, precipitous, and prolonged" drop in paid search advertising (see the chart here).

At the time of the announcement of the Google settlement, I suggested that because of FDA's involvement in the case, the agency delayed issuing guidance relating to the proper use of Google Adwords for branded Rx advertising. I suggested that the FDA did this to force Google to the bargaining table and to ultimately accept the draconian settlement terms mentioned above. In other words, FDA was holding Google's pharma Adword business "hostage" until a settlement was reached. See my argument here.

Looking at the above timeline, however, I now believe the 14 letters were sent so that Google might be more easily persuaded to run illegal drug ads to make up for the revenue lost from legitimate Rx drug ads. If true, this looks like a form of entrapment.

Keep in mind that the type of ads targeted in those 14 letters had been running for many years and that I, for one, maintained they were illegal starting way back in 2006 (see The "Girl from Google"). At the time, I submitted a written complaint to the FDA. Why did the FDA wait almost 3 years before getting around to stopping these ads? The answer, I believe, is what I surmised above -- it was simply a ploy to incentivize greedy Google ad executives to fall for the sting. According to the WSJ article, Google's ad executives "worked with Mr. Whitaker to find a way around Google rules."

P.S. Google may have tried an "end run" around the entrapment by coming up with a new ad format for Rx drugs that addressed the issue cited in the 14 FDA letters. This format was announced at the November, 2009, public hearings (see "Is Google the New FDA?"). The ad was actually "beta" tested by Bayer, but to date the FDA still has not formally approved the format and not many other drug companies have used it.

Is There a Cure for Mediocre Pharma Mobile Apps?

For new pharma marketing Graduates, I have just one word for you. Are you listening? Mobile!

Mobile is the new "shiny thing" of interest to pharmaceutical marketers. As evidence of this, there are more and more drug industry conferences that are dedicated to mobile or have tracks or whole days dedicated to mobile. Mobile Healthcare Communications 2012, for example, is one of them. I will be at that conference moderating a roundtable discussion on "Overcoming Mobile Healthcare Compliance Challenges." [The producers of that conference are a client, but I am not being paid to write this post.]
According to my currently-running "Predicting the Future of the Drug Industry: 2012 and Beyond" survey, 72% of respondents agree/strongly agree that the next "BIG opportunity for targeted marketing to patients and physicians is mobile apps on smart phones."
Until recently there were not many pharma mobile applications out there worthy of writing about. previously. Most marketers were discussing only SMS (text messaging) as the best example of using mobile to motivate people to take their medicine. Boring!

I have written about issues related to use of mobile devices by pharma, including the following posts and articles:
However, most pharma mobile apps that I have seen are pretty mundane as far as marketing/advertising is concerned. There are a few that focus on consumers such as the Sanofi-Aventis GoMeals app, which IMHO has absolutely no marketing ROI for S-A although it is only one part of an overall marketing plan to position S-A as a player in the diabetes area.

Other apps are aimed at physicians, such as Janssen's "Psoriasis" (PASI) app for the iPhone and iPad that may need FDA approval as a medical device (see here).

There are no pharma apps that I know of that directly help to sell drugs or vaccines. I mention vaccines because I just found out about a P&G "Vicks" branded mobile app/device combination that could be a model for improving the sale of vaccines, especially for the flu. It's a mobile advertising campaign for a behind-the-ear thermometer by Vicks that is "designed to display the ad only in areas where there is a high incidence of the flu and only to mothers, the primary purchasers of thermometers" (see "Using Google Data on Smartphones to Target Consumers for Ads").

Couldn't an app like this be created by a pharma company to promote its flu and other vaccines? Or even OTC medicines during allergy season? Perhaps even Rx drugs if Google had the right kind of targeting data?

There are, of course, some regulatory hurdles to overcome. Since the Vicks app is integrated with a device (thermometer), perhaps it should be regulated by the FDA as a medical device.

Another challenge is the relationship between Google and the pharma industry. While Google is bending over backwards to provide help to consumer goods agencies about how best to do display advertising via its network (see "Google Increases Investment in Display Ads"), I don't think Google is providing the same level of services to pharma agencies. A representative of Google recently said "pharma needs to leverage the Internet" and that "pharma was not considered a key client by Google because of pharma’s low spend" (see here).

To create truly useful mobile apps that have ROI, pharma needs to invest more in interactive media overall. Otherwise, it will continue to develop marginally useful apps that are used once and then forgotten, IMHO.

Three Companies Compete for Diabetes Market Share Using Recipes Rather Than Product Efficacy

Whose recipes will reign supreme?!

My Twitter friend, @serious_skeptic, who has Type 1 diabetes, just tweeted: "why the hell would anyone want a recipe from a DRUG company anyway???" during a conversation we were having about celebrity chef Paula Deen and her new relationship with Novo Nordisk (read this for the background).

From reading comments made by other people with diabetes on influential blogs such as DiabetesMine, I get the impression that most do not think Paula Deen was a smart choice as a pharma-paid diabetes treatment spokesperson. Of course, most of these people may come from the "hoity-toity" northeast and LA region of the country that is, according to Novo Mordisk, not representative of the majority.

"and what is this b.s. NYC/LA bias to which Novo refers? I don't live in either & Deen still disgusts me," says @serious_skeptic.

Getting back to the original question about drug company recipes... Novo's deal with Deen propels the company into crowded territory. At least two or three other major pharmaceutical companies tout "diabetes-friendly" recipes, including Merck, which markets Januvia, and Bristol-Myers Squibb/Astrazeneca, which together market Onglyza. With Novo (which markets Victoza), those were the top three Google search results on "diabetes certified recipe" (at least the top 3 PAID results; it's hard to tell these days what are paid and unpaid search results when using Google!):

What these drugs have in common is that they treat type 2 diabetes, NOT type 1. Instead of competing on the effectiveness of their treatments, these companies are competing based on which one offers the best diets. Novo just trumped the competition on that score by signing on a celebrity chef, which none of the others has done at this point.

The emphasis that these drug companies place on DIET rather than efficacy indicates to me that without the diet, these drugs simply would not work very well or work equally well.

Novo Nordisk Defends Choice of Paula Deen Over Anthony Bourdain (for example) as Celebrity Chef Spokesperson

Yesterday, I spoke with Ambre Morley, Associate Director, Product Communications, Novo Nordisk, who answered my questions about why her company teamed up with celebrity chef Paula Deen as a spokesperson for type 2 diabetes treatment (listen to podcast of the interview here). In case you don't have time to listen to the whole interview, here are my takeaways regarding why Novo Nordisk chose Deen.

I asked: "Why did Novo Nordisk decide to work with Paula Deen as a spokesperson? Did she or her agents approach you?"

Morley claimed that Novo Nordisk was looking for a celebrity chef they could hire to develop diabetes-friendly menus for people with type 2 diabetes. As one commenter said on the Diabetes Mine Blog: "Surely the drug companies could choose spokesmen who are role models for their community."

Why, for example, did Novo Nordisk choose Paula Deen, noted for her fatty, calorie-rich recipes, versus Mario Batali or Anthony Bourdain, both of whom are celebrity chefs with shows on TV (although not necessarily better "role models")?

"We wanted to take really good recipes and change them -- have them certified by dietitians. That's how it started. We then started to look for chefs that could help us promote this campaign. Honestly, Paula Deen popped into my head," said Morley. "How cool would it be," said Morley, "to challenge Paula to change some of her famously tasty, and butter-rich, and really unhealthy recipes?" Probably not much of a challenge if you throw her sons -- Bobbly and Jamie -- into the deal. The sons have broken with their mama and have their own Food Channel show titled "Not My Mamma's Meals." Paula tries to promote her sons every chance she gets. On the Today Show, for example, she tried to do it at the end of the interview but Al Roker cut her off (see it here). No biggie! Her sons are part of the deal with Novo Nordisk.

So, Morley et al called Deen; Deen did not call Novo Nordisk. Morley said that she had "no idea" that Deen had diabetes (she has people who can validate this story, she said), which I suppose is possible considering how secretive Deen was for three years about her condition while all the time promoting her "unhealthy" recipes.

Chef Anthony Bourdain, who has never been a fan of Ms. Deen‘s, told Eater.com: “When your signature dish is hamburger in between a doughnut, and you’ve been cheerfully selling this stuff knowing all along that you’ve got Type 2 diabetes ... it’s in bad taste, if nothing else” (see here).

Aside from getting a package deal with Deen and her sons, why else did Novo Nordisk choose her as a spokesperson?

Morley did not want to choose a chef based in food-snobby New York or Los Angeles, which are the haunts of Bourdain and Batali. "I can't say that a chef in New York -- even a chef with diabetes -- who has a hoity-toity fancy restaurant would have the same impact on people as Paula Deen would. It came down to: Who would the greatest number of people look at and say that person was like me?"

Regarding the incidence of type 2 diabetes, Morley went on to say that "there's a huge difference between New York and LA and the rest of the country." Reality in the northeastern part of the country is different than in the South, for example. "In the Southeast and in Middle America," said Morley, "when people are diagnosed with diabetes, they don't run out and shout and tell the world that they have it," said Morley. True that! But most people down South also are not TV celebrities and role models for millions of people. I have to agree with Bourdain. Deen exhibited "bad taste" (I would say "deception") by keeping her diabetes secret while hawking "unhealthy" recipes to millions.

Morley claims that a lot of criticism of Deen is unfounded and she implied that the criticism demonstrated a NY-LA bias and that other celebrities would not be subject to the same kind of personal attacks endured by Deen. I would have to disagree, because I for one have often criticized the use of celebrities by pharmaceutical companies. See, for example, my posts about Phil Mickelson (eg, "Amgen Blows Its Marketing Budget on Phil Mickelson Campaign").

Pfizer & PhRMA Lobby in Support of SOPA

Steve Jobs once said that he'd rather be a "pirate" than join the navy. What he meant was you must think out of the box to innovate. But the world's "innovative" drug industry is the "navy" as far as lobbying in support of the "Stop Online Piracy Act" goes.

The legislation's short title is SOPA (H. R. 3261; find it here). There are several anti-SOPA Facebook pages and at least one called "Boycott SOPA (the companies lobbying for it)." You can get the official list of companies and organizations lobbying in favor of the bill here. Pfizer and PhRMA are on that list. Why? See below.

Many technology companies and web sites have organized a day of protest (today) against this bill and the companion "PIPA" bill ("Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011" or the "PROTECT IP Act of 2011"; find it here). Protesting companies include Google, which has put a censorship bar across its log, and Wikipedia, which has shut down totally today.

Here's some background as published today in the New York Times (here):
The bills in Congress, pushed by Hollywood studios and other big media companies, target websites that let users download pirated movies, TV shows, music and other material in violation of U.S. copyright law. Most of these sites are outside of the United States, but the legislation would give the Justice Department and private companies tools to block them from American consumers. 
For example, Google could be forced to drop an offending site from its search engine results. Or the government could go to court to stop a U.S. company that facilitates online payments to a suspected infringing site. Internet companies say they have neither the time nor the resources to monitor every link on a website or post by a user.

Google, Facebook, eBay and other new media companies also object to rogue sites, but they have repeatedly said the Stop Online Piracy Act, or SOPA, in the House of Representatives goes too far, hurting investment, innovation and the open nature of the Internet. 
Why do Pfizer and PhRMA support these bills? Simple. They believe it is necessary to prevent "counterfeit" medicines from being sold to US consumers by companies outside the US. At least that's why I think they are supporting these bills. I don't find any press releases or blog posts about it on Pfizer's or PhRMA's site. Perhaps they will respond to this post and tell us in their own words why?

If the industry needs help from the government to prevent counterfeit medicines from reaching US consumers, why not support specific laws for that purpose instead of this legislation that potentially can be used to limit the rights without due process of many online publishers -- who do not have anything to do with counterfeit medicines?

UPDATE (Jan 19, 2012): AstraZeneca Backs Counterfeit Drug Legislation

As if AZ heard what I said about pharma sponsoring more specific anti-drug counterfeiting laws, I just learned that's exactly what AZ is doing. From the AZ Health Connections Blog:

AstraZeneca sent a letter to members of Congress today to express support for legislation that would increase penalties for those convicted of counterfeiting prescription medicines. The letters sent to bill sponsors Rep. Patrick Meehan, Sen. Patrick Leahy, Sen. Chuck Grassley and Rep. Linda Sanchez note that the issue of counterfeit medicines is particularly serious via “Internet pharmacies”:
While the total incidence of counterfeit medicines sold in "brick and mortar" pharmacies in the U.S. is estimated to be less than 1 percent of the total market value, the World Health Organization estimates that over 50 percent of medicines purchased from Internet sites without a physical address are counterfeit. 
You can see the World Health Organization fact sheet on the issue here.

The letter concludes:
 Although the trafficking of counterfeit drugs is currently illegal in the United States, the penalties for such activity are the same for the trafficking of other products. The Counterfeit Drug Penalty Enforcement Act would significantly and meaningfully increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public. The proposed sanctions and sentencing guidelines would serve as powerful deterrents to pharmaceutical counterfeiting, greatly benefitting patient safety and health. 
 Additional details on the bill can be found here.

My Bad! Paula Dean Shills for Novo Nordisk, Not Novartis

[Alternative title for this post: "Paula Deen and Diabetes Prevention: A Recipe for Disaster!"]

Last week I reported on a story that celebrity southern-style chef Paula Deen has type 2 diabetes and that she is a spokesperson for Novartis's diabetes franchise (see "Sanofi vs Novartis: Paul Sorvino vs. Paula Deen").

It turns out that the source of this information confused Novartis with Novo Nordisk, another pharmaceutical company famous for using celebs to shill for its diabetes treatments (see, for example, "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!").

"The rumors that Novartis has signed a multi-million dollar spokesperson deal with Paula Deen for a diabetes treatment are not true," a Novartis rep told CBSNews.com. "Novartis is not working with Ms. Deen."

It's official! Deen is now shilling for Novo Nordisk (see "Paula Deen Now Novo Nordisk Diabetes Paid Spokesperson" and Novo's press release). Yes, she's being paid for her new role with the drugmaker, Deen says. "Talking about money is garish. It's tacky. But, of course, I'm been compensated for my time. That's the way our world works."

Ha! Ha! Talking about money is "garish"! That's rich! Only people with lots of money can say that! Senator Grassley should investigate the money that pharmaceutical companies pay celebrities such as Paula Deen and push to have these payments made public just like pharma payments to physicians must be made public.

Deen uses Novo Nordisk's Victoza, a once-daily, non-insulin injection that may improve blood sugar levels in adults with type 2 diabetes when used along with diet and exercise. [my emphasis]

It appears that Deen will NOT change her lifestyle -- ie, eating habits -- much to encourage PREVENTION of type 2 diabetes.
"Type 2 diabetes is like 'Russian roulette' when it comes to whom it's going to strike, Deen says. 'It's about heredity. It's about age, lifestyle, race. I'm the only one in my family who has it. My grandmother cooked and ate like I ate, and she didn't have it.'

"Deen says she's not going to change the focus of her cooking shows because of diabetes. 'I suspect I'll stick to my roots but will say a little louder, Eat this in moderation.'"
Eat this Paula Deen donut-bacon-hamburger sandwich in "moderation:"

Novo Nordisk appears to be abandoning life style changes it has supported in the past or maybe it's just exhibiting a form of PR-Marketing schizophrenia.

Just this past November on World Diabetes Day, for example, the company issued a press release in which it announced that it was a partner in the World Diabetes Day campaign and that it "has planned or co-sponsored a variety of activities throughout the world...[all of which] are focused on increasing awareness and improving knowledge of diabetes and its prevention" (see "Dramatic increase in diabetes prevalence calls for action").

The two activities just do not fit together! The first (sponsoring World Diabetes Day) is a matter of public relations and the second (Paula Deen) is marketing's turf -- never the twain shall meet.

Novo and Paula have launched a new Website whose very name hints at the new emphasis: "Diabetes in a new light!™" (www.diabetesinanewlight.com/). Apparently, Novo Nordisk is more interested in helping people live with type 2 diabetes by treating it than it is in helping 26 million Americans prevent it.

IMHO, this shows that pharmaceutical companies are not very trustworthy when it comes to their public stance on disease prevention.

Sanofi vs Novartis: Paul Sorvino vs. Paula Deen

It is rumored that celebrity southern-style chef Paula Deen will soon announce that she has diabetes (surprise) and that she is a spokesperson for Novartis's diabetes franchise (see "Rumors Say Paula Deen Has Diabetes, Will Work for Novartis"). She will compete with Paul Sorvino and daughter who are currently the diabetes spokespeople for Sanofi (see "Diabetes Costars").

How Novartis plans to position Deen as a spokesperson for diabetes awareness should really be interesting. She's not much of a proponent for healthy lifestyle changes, which PhRMA recommends should be part of every direct-to-consumer advertising campaign.

According to the article cited above, "Deen has faced withering criticism for the high amounts of fat, salt and sugar in her dishes. When Deen’s cookbook for kids, 'Lunch-Box Set,' was published in 2009, Barbara Walters asked her, 'You tell kids to have cheesecake for breakfast. You tell them to have chocolate cake and meatloaf for lunch. And french fries. Doesn’t it bother you that you’re adding to this?'"

In 2009, I took a road trip down south with my son (see photos here). A highlight was when we had lunch  at "The Lady & Sons" — the restaurant Deen owns in Savannah, Ga. We ate the "fried chicken, ribs, cheesy meatloaf and sweet potatoes" for which the restaurant is famous. Here's the scene that day outside the restaurant (TIP: you may not have to wait for a table if you are willing to eat upstairs in the bar; of course, you have to be thin enough to fit on the stools, which may not work for most of these people waiting on line):

While it's a good idea to have an overweight person as a diabetes spokesperson, it's quite another to have an UNAPOLOGETIC overweight person who recommends cheesecake for kids' breakfasts! It's sort of like having a "vulture capitalist" claim he creates jobs!

"The rumors that Novartis has signed a multi-million dollar spokesperson deal with Paula Deen for a diabetes treatment are not true," a Novartis rep told CBSNews.com. "Novartis is not working with Ms. Deen."  See "Novartis rep: There's no deal with Paula Deen."

[See "My Bad! Paula Dean Shills for Novo Nordisk, Not Novartis" for a followup to this post.]

Are You Part of My Social Media Mosaic?

For a buck ninety-eight, I was able to make and download the following Pharmaguy mosaic image comprised of photos of my Facebook friends and in my photo album. Your face may be one of the images that was used to create this image on the mo.saic.me Web site.

Sorry if no one asked your permission to use your image!

At $1.98 a shot, it's going to take a lot of mosaics to pay for that ".me" domain name!

I got the idea for this from Marc Monseau's mosaic (here) where my image appeared just below his nose -- like a booger!

FDA Sends Warning Letter to Website to Cease & Desist: It Doesn't

@skypen posted this tweet recently: "Interesting warning letter for flu med for false claims via web, twitter & facebook http://t.co/FWI0y4Ch," which I found in the ePharma Pioneer Club Forum.

What I found interesting about this letter is that it addressed an issue more serious than the typical "false claims" letter that Rx pharma companies sometimes receive. This letter pointed out that a product ("Triple Flu Defense") was being "promoted for conditions that cause the product to be a drug" subject to FDA regulation. "Triple Flu Defense," however, never submitted a new drug application to the FDA for marketing approval. Hence the letter.

FDA pointed out that several unsubstantiated efficacy claims were made, such as:
  • “Relieves Flu Symptoms” 
  • “Eases Flu Vaccine Side Effects” 
  • “…[T]his product is of inestimable value in the prevention and mitigation of influenza.” “Triple Flu Defense can also be used to alleviate side effects from the flu vaccine.”
In addition, said FDA, the website "includes claims in the form of testimonials that establish the intended use of your product as a drug. Examples of these testimonials include the following:
  • “It really works. My husband didn’t take the formula and got sick and I didn’t. It has no side effects.” 
  • “I have been around people with the flu and haven’t gotten sick since taking Triple Flu Defense.” 
  • “I had been sick for a week with the flu and thought I was never going to feel better. I took two doses of Triple Flu Defense and felt a lot better. It works great.” 
  • “I'm one of the few people I know who didn't get the flu this past year because of Triple Flu Defense!”  
  • “I took Triple Flu Defense during the season. I didn’t get sick all winter.”
Pretty amazing claims!

When I accessed the Triple Flu Defense Web site (here), I expected to see that it had been taken down in response to the FDA's waring. After all, the FDA sent the letter via UPS overnight on December 14, 2011 and demanded action within 15 days. But it's almost a month later and all the claims are still there (see screen shot; click to enlarge and read the claims).

In contrast, when Rx Web sites are cited for violations by the FDA, the offending pages are gone by the time you learn about the letter!

Despite Increase in DTC Ad Spending, WebMD Suffers

2011 is shaping up to be a good year for pharma direct-to-consumer (DTC) advertising -- that is, broadcast advertising, NOT Internet advertising.

According to Nielsen data prepared for DTC Perspectives Magazine, total pharma DTC ad spending -- excluding Internet advertising -- increased 3.2% for the first 3 quarters of 2011 vs. the same period in 2010 ($3.045 billion in Q1-Q3 2011 vs. $2.951 in Q1-Q3 2010).

A chart of the top 25 or so drugs promoted in Q1-Q3 2011 in shown below (click on the chart for an enlarged view).

This is good news for TV, which raked in 64% of the broadcast DTC ad dollars during that period and magazines, which raked in 30%. Newspapers and radio shared the scraps left over.

What about Internet DTC spending?

Recall that in October I reported that a representative of Google said "pharma needs to leverage the Internet" and that "pharma was not considered a key client by Google because of pharma's low spend" (see "Double Dip in DTC Ad Spend!").

Of course, Google is concerned primarily with search advertising, which is often said to represent about 40% of the industry's total online advertising spending. But what about online display ads, which are major sources of income for health portal sites such as WebMD?

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").

FDA's Advisory Committee Voting Double Standard

I learned today that the FDA allowed physicians with ties to Bayer to participate and vote in an advisory committee weighing whether or not the benefits of four popular Bayer AG birth-control pills outweigh the blood-clot risk (read the WSJ story here: "FDA Advisory Committee Members Had Ties to Bayer").

At least one of the physicians (Paula Hillard, Stanford Univ; see her financial disclosure info here) was a Yasmin advocate. According to a Bayer document released during litigation, Hillard "enable[d] us [Bayer] to now have another huge ... Yasmin advocate here in Nor Cal -- she will be well utilized!"

Hillard, the advocate, was allowed to vote on the issue.

In the same story, it was noted that drug-safety crusader Sidney Wolfe -- who was appointed to a four-year term on the FDA's Drug Safety and Risk Management Committee (see "Wolf(e) at DTC Piggy's Door Huffing and Puffing") -- was NOT allowed to vote "because he had publicly criticized the drugs' safety in newsletters published by his Public Citizen Health Research Group."

So, an "advocate" of a drug is allowed to vote whereas a "critic" of a drug is not allowed to vote. This is an astonishing double standard, IMHO.

This little excerpt from the WSJ article is also interesting:
The FDA says members of the public speaking before advisory committees must declare any financial relationships to the relevant drug maker, to "ensure ... transparency." However, committee members must disclose potential conflicts only to the FDA, which doesn't generally make the information public.

Jill Hartzler Warner, an FDA official who oversees advisory committees, said the agency is "prohibited from giving the public any information contained in a financial disclosure" from committee members. When picking committees, the FDA weighs "whether a meeting would affect the financial interest" of a panelist. The agency also does "look at whether past relationships would give the appearance of being a conflict," she said.
I was not aware that the FDA is "prohibited" from supplying information contained in financial disclosures, but it may be a moot point in a year or so when the physician sunshine act is in full effect and all payments to physicians are made public. We'll just have to wait for that and do our own research. Still, with FDA's double standard regarding voting privileges, it won't much matter how much transparency there is in who serves on these committees!

P.S. For more on how the FDA determines whether or not a physician's financial conflicts disqualifies him or her from serving on FDA advisory committees, see "FDA Advisor Rule Loophole?" where you'll find a complex chart depicting FDA's "Algorithm for Considering Advisory Committee Member Participation."

P.P. S. For some more background on Wolfe vs FDA regarding Wolfe's participation in this committee, read "FDA Pulls Wolfe Off Panel Over ‘Intellectual’ Conflict" (Pharmalot).

Thera Max YouTube Video "Social Media Strategy" Makes Americans Look Like Fools!

"A reporter in Times Square gathered over 200 random people and allowed them to try Thera Max™ Cold and Flu right on the spot. The results provided would give a non-biased, random and unscripted evaluation of the product and the results it provided. The overall consensus was, 'It really works.'"

According to the press release (read it here) this was the result of "A Social Media Strategy in Times Square [that] Boasts Great Results for TheraMax Cold and Flu."

What's the social media component? Videos from the TheraMax "No Cold Here -- Times Square, NYC" promotion have been uploaded to the Thera Max Facebook and YouTube pages.

Luckily, this social media "strategy" hasn't garnered very many views on YouTube (see video here). There have been only 148 views so far and half of them were by me!

I say "luckily" for a couple of reasons:
  1. The claims of efficacy made in the video for this "homeopathic remedy of ingredients pre-approved by the FDA" are shameful. "Awesome", "no nasal congestion here." etc. No wonder Rx drug marketers have social media envy! 

  2. The "random people" trip all over themselves trying to promote the product as if they were auditioning for a TV ad spot! Wait! They ARE auditioning! "On February 1, 2012, one Grand Prize Winner will be selected at random to receive a TheraMax customized iPad2," says the press release!
I don't have the stomach to see what's happening on the Facebook page!

The following montage of frames from the video demonstrate the depths to which some people will stoop for a chance to star on YouTube and win a lousy iPad2!

Lilly Sales Reps Learn Marketing Lessons From Disney's Animal Keepers

Lilly sales representatives are learning about customer service by observing Disney Animal Kingdom workers as they "[greet] families at the gate and [answer] questions around the attractions," according to an article in today's Wall Street Journal (read "Drug Sales Reps Soften Pitches").

"Lilly's most recent national sales meeting, held at Disney's business training institute in Florida in February, was devoted to customer service, not product training," said the WSJ.

"Increasing physician satisfaction, it turns out, is a much better way to promote a pharmaceutical agent than simply telling them to write more prescriptions or what the benefits" are, said David Ricks, president of Lilly's global business unit.

I'm not sure it was necessary for Lilly to bring its sales reps to a Disney resort in order to learn about the "new service model," which I have been writing about for the last few years in collaboration with Kantar Health (a client). You can read the latest installment, "Stakeholder Effectiveness: Maximizing the Value of Your Interactions with Multiple Stakeholders" (here - use discount code '101701stake'), which ranks the top 15 pharmaceutical companies on how well their sales reps provide services desired by physicians. Also, you can read the first article in the series, "Reinventing the Sales Model: Moving from Sales to Service" (pdf).

Each year Kantar Health asks physicians in the U.S. and Europe if they have started to notice a move toward a “service model” experience, where other services are emphasized beyond sales reps detailing physicians, such as patient education and information and internet-based services. They quantify this using what is called a TRI*M™ index. The lower the TRI*M, the better service provided and the higher the ranking. The 2009 through 2011 U.S. Primary Care Physician rankings are shown in the following chart (click on it for an enlarged view).

Lilly improved its rank somewhat in the last two but is still not among the "Top Tier" companies such as Pfizer, Merck, and GSK. Hopefully, Disney's animal trainers will help improve Lilly's TRI*M index in 2012.

Some Interesting Numbers Regarding US Sales Reps & Budget

As reported in the WSJ (op cit), "the industry has slashed 33,000 sales jobs in the U.S. from its peak five years ago, when 105,000 representatives flooded the zone. Most recently, AstraZeneca PLC said it would cut its U.S. sales staff by 24%, or 1,150 jobs. The industry spent $14.5 billion on marketing in the U.S. in 2010, down about 15% from five years ago, according to Cegedim Strategic Data."

Predicting the Future of the Drug Industry: 2012 and Beyond

It's time to revisit a survey I ran 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).

Predicting the Future of the Drug Industry: 2012 and Beyond

You can take the survey here. But before you do that, let's review the first-round of results (ie, responses collected from 2 December 2009 through 8 January 2010). Events since then may have made some of the following scenarios more or less likely. You tell me.

The scenarios -- with my updated comments included in brackets [] -- that are included in the survey are as follows (see the chart afterward for the first-round results):
  1. New follow-on biologics legislation in the U.S. will increase competition from generic equivalents and eventually decrease brand profits. [I think the legislation is still bogged down and when finalized may not have much impact within the time frame specified.]
  2. Broadcast (ie, 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.]
  3. The European Union will finally allow Direct-to-Consumer (DTC) advertising to its citizens. [The European Commission, the executive arm of the EU, recently ruled that pharma companies would not be allowed to disseminate information about drugs and their indications beyond a narrow set of circumstances. For the details, see, "In Rejecting Proposal, EU Dashes Drugmakers’ Hopes of Having a Voice"]
  4. Internet-based drug promotion (including search engine marketing) will overtake TV-based DTC in the U.S. in terms of dollars spent. [There's still time for this to happen. I'm guessing that right now only about 5% (maybe 10% if you include search advertising) of pharma's DTC advertising budget is spent on Internet advertising whereas TV accounts for over 50% of the budget. See "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"]
  5. Due to decreasing effectiveness of traditional physician detailing and rise of non-personal detailing, the role of traditional sales representative will become obsolete. [I'm surprised that over 50% of respondents think this is likely to happen before 2020 (see chart below). Perhaps a sign is the recent closing of Pharmaceutical Representative Magazine (see here). Also read this article: "Consequences of eDetailing Technology".]
  6. New healthcare reform legislation will dramatically increase the sales of drugs in the U.S.
  7. Extensive outcomes data available to payers and comparative effectiveness research will force the industry much further down the path of pay-for-performance (ie, adopt a more flexible approach to pricing). [For background in this, read the article "A Case for Supporting Comparative Effectiveness Research".]
  8. Patients will become even more influential and empowered in making healthcare decisions as they are forced to pay a larger share of costs and/or have access to health information from a variety of sources. [For more background on this, read the article "The Empowered Patient: What It Means for Pharma Marketers".]
  9. Despite lack of innovative new drugs and/or generic competition, sales of brand drugs worldwide will show a sharp increase due to increased demand in emerging markets (eg, China). [See the following articles: "Getting Market Research Right in Emerging Markets", "Getting Market Research Right in the Middle East", and "Getting Market Research Right in India & China".]
  10. More efficient targeting of drugs and marketing to specific patient populations will greatly increase effectiveness and decrease side effects of drugs. [See, for example, "New Big Pharma Economies of Scale: Less Patients Needed to Reach Blockbuster Sales". At least one targeted therapy (I can't recall which), however, recently failed and that may cast a shadow on progress in this area.]
  11. Social media marketing will become a significant part (>10%) of the pharmaceutical marketing mix. [Hmmm... A lot of people seem to believe this is likely (see chart), but FDA's delay in issuing guidance may have dampened the outlook for pharma use of social media.]
  12. The next BIG opportunity for targeted marketing to patients and physicians is mobile apps on "smart phones." [To prepare for this, I recommend you read the article "Everything You Need to Know About Mobile Platforms". Take the survey and you will get a discount code that allows you to get this at no charge.]
  13. Pharmaceutical and biotech companies will continue to increase their outsourcing of clinical trials and related drug development. Outsourcing will account for more than 50% of R&D spending by 2019.
The following chart summarizes first-round (prior to January 2010) survey results. Please take the survey now and help me get a more current view of what may be dow the road.