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:

• FDA Issues Long-Awaited Guidance - for Mobile Medical Apps. Janssen, Look Out!
• The iPad as a Pharma Marketing Platform
• Challenges of Regulating Mobile Medical Apps
• Mining Mobile Health App User Data
• Checking Under the Hood of Pharma Mobile Apps
• Everything You Need to Know About Mobile Platforms

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!


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