Retro Relpax Web Site Features Woman Mopping the Floor. Inspirational? Not!

The "DDR on DTC" column in the August 2012 issue of MM&M magazine ripped into a print ad that showed a woman migraine sufferer being able to mop the floor after taking the Pfizer anti-migraine headache drug Replax.

"DTC ads used to be over-aspirational," said the author, Deborah Dick-Rath, "we saw relieved arthritis sufferers running marathons or playing Frisbee. With Relpax, the insight seems to be that sufferers just aspire to do such everyday activities as mopping the floor...We hope that Relpax is a success for Pfizer and that migraine sufferers find relief. We also hope they get (strictly aspirationally) excused from swabbing the deck" (see "DDR on DTC: Relpax").

Here's the ad that DDR reviewed:

This is probably the result of Pfizer's conservative view of what modern women aspire to at 11:00 Am in the morning (note the clock).

I couldn't find this ad in a recent issue of People Magazine, which is the publication in which DDR found the above ad. Instead I found this much more politically correct, although still not too inspirational, ad:

In this version, two hours after taking Replax, the migraine sufferer is able to go out and do whatever her business is -- probably commuting to work given that the clock is showing 8;00 AM (or is it PM?).

Perhaps Pfizer read DDR's column and revised the print ad campaign, at least as far as image is concerned. Surprisingly, however, the Replax.com Web site still portrays the woman mopping the floor:

It appears that it takes longer to swap out a Web image that a print ad image.

Pfizer is asking Replax.com visitors to tell their "stories" by submitting photos or video. "Tell us about your experience with migraines by submitting a story," says the promo page (here). "Your story can include a photo or video. If chosen, your submission could be featured on RELPAX.com."

I don't imagine a single submitted photo or video will feature a woman mopping the floor. Do you?

You can tell that pharma marketers are getting desperate when they have to beg consumers to submit stories to compensate for the fact that their image of the modern consumer dates back to the 1950's.

Lipitor U.S. Sales Tank 70% in 2012 vs 2011!

According to Drugs.com, Lipitor U.S. sales in Q2 of 2012 were only 30% of what they were in Q2 2011 ($579 million vs. $1,949 million, respectively (see chart below; Source: http://www.drugs.com/stats/lipitor).

Meanwhile, sales of Crestor (a competitor anti-cholesterol drug) increased only somewhat during the same period (see chart below; Source: http://www.drugs.com/stats/crestor).

I conclude that most of the loss of Lipitor sales was due to direct competition from generic versions of Lipitor now currently available, which is further proof that Pfizer's "innovative" attempts to stem the generic Lipitor tide has failed (see also "Pfizer Throws In the Lipitor Marketing Towel").

Lilly Overtakes Pfizer as Biggest DTC Advertising Spender!

According to cegedim Strategic Data, Lilly overtook Pfizer in total direct-to-consumer (DTC) spending in April, 2012. The chart below shows the top 10 DTC spenders between July 2011 and April 2012.

Pfizer spent nearly $900 million in DTC advertising in 2011. $220 million of that was for Lipitor. I predicted that Lipitor would hold the "Key to DTC Ad Spending in 2012" (see here) and this chart proves it.

Lilly's Cymbalta and Cialis were the #2 and #3 highest in DTC ad spending in 2011. It looks like they will be #1 and #2 in 2012.

Is Type 2 Diabetes Drug Marketing Responsible for Misdiagnosis of Type 1 Diabetics?

A Wall Street Journal article documents several cases of people being misdiagnosed by general practitioners as having Type 2 diabetes when they actually have Type 1 diabetes, "a substantially different condition" (see "Wrong Call: The Trouble Diagnosing Diabetes"). According to the article:

"An incorrect diagnosis usually occurs in the offices of primary-care doctors, many of whom haven't received adequate education in medical school about rising rates of Type 1 in adults and how to diagnose it. 'It is not on their radar because they see so much diabetes and it is by far mostly Type 2,' said Irl B. Hirsch, professor of medicine at the University of Washington Medical Center in Seattle."

As I continued reading, I couldn't help but wonder if the current competition among drug companies to sell Type 2 diabetes drugs has something to do with this. Fierce marketing of these drugs - see box below - may be contributing to emphasizing Type 2 diabetes on GP's "radar screens."

The Three Type 2 Diabetes Drug "Amigos" Januvia - marketed by Merck Onglyza - marketed by Bristol-Myers Squibb/Astrazeneca Victoza - marketed by Novo Nordisk See "Three Companies Compete for Diabetes Market Share"

In each case cited in the article, misdiagnosed patients were taking oral drugs, none of which were mentioned by name, and none of which are effective or approved by the FDA for treating Type 1 diabetes. "For six years, Mr. Jones [a patient] treated what had been diagnosed as Type 2 diabetes. He changed his diet and took three oral medications daily." It's likely that at least one of those drugs was one of the "Three Type 2 Diabetes Drug 'Amigos'" mentioned above.

Of course, many GPs would probably misdiagnose patients as having Type 2 diabetes when they actually have Type 1 diabetes even without being bombarded with marketing for Type 2 treatments. But having multiple pills available to prescribe makes it easier, in my opinion, to avoid taking the patient down the path to a possible Type 1 diagnosis.

The ultimate responsibility for misdiagnosis, however, must rest with the physician and not the pharmaceutical marketer, unless of course, the marketer offers physicians inducements (ie, money or non-monetary rewards) for prescribing products.

On that note, I also read a story in today's WSJ about Pfizer and other drug companies bribing doctors to prescribe their drugs. Pfizer settled with the DOJ -- admitting nothing -- but paid $60.2 Million to "Resolve U.S. Allegations That It Used Illegal Payoffs to Win Business Overseas."

Of course, such things do NOT happen here in the U.S.

Pfizer and Janssen Halt Alzheimer Drug Development: Why Not Try Gamification?

"In the wake of another negative trial with the anti-amyloid biologic drug bapineuzumab, Pfizer and Janssen said they were halting development of the product for mild to moderate Alzheimer's disease," reports medpage today (here).

Pfizer may have had high hopes for this drug because it already launched a multichannel marketing/PR campaign centered around "getting old" (see "Pfizer's Social Media Initiatives are Getting Old") and this drug in particular (see "Can Pharma Cure Alzheimer's Disease? A Pfizer Pre-Launch Multichannel Marketing Case Study").

I'm not sure what other Alzheimer products Pfizer is currently working on, but maybe it's time for it think out of the box. Perhaps it should look into gamification as an alternative strategy.

You might ask, "Are you serious John? Just yesterday you pooh-poohed gamification as an alternative to ADHD drugs" (see "Cure by Gamification: Science or Wishful Thinking?").

True that. I still believe that games will never be approved by the FDA for treatment of a medical condition and doctors won't prescribe them even if they were approved. But that doesn't mean games cannot be effective in the treatment of Alzheimers Disease by slowing its progression, which has been the goal of clinical trials of drugs like bapineuzumab.

There is actually some SCIENCE published in a peer-reviewed medical journal (JAMA's Archives of Neurology) that purports to have found a link between “brain-stimulating activities” and levels of protein -- ie, β-amyloid -- thought to cause Alzheimer’s disease (see "Brain Games May Help Thwart Alzheimer’s: Study"). The authors of the study state:

"We report a direct association between cognitive activity and [11C]PiB uptake, suggesting that lifestyle factors found in individuals with high cognitive engagement may prevent or slow deposition of β-amyloid, perhaps influencing the onset and progression of AD."

At least one patient support group supports the idea that games might be helpful in thwarting Alzheimer's Disease (see this LivingStrong web site page: "BRAIN GAMES FOR ALZHEIMER'S").

For anecdotal evidence, I have been solving 2-3 crossword puzzles per day (as recommended by LivingStrong) for a couple of years and am happy to say that I have not been diagnosed with Alzheimer's -- yet. Unfortunately, I did not have a brain scan before starting nor do I have a control group so as to scientifically prove or disprove that I am not slowly developing the disease.

Nevertheless, I still think it's unlikely that any drug company would get into the business of "drug gamification" -- ie, developing games approved by the FDA for treatment of medical conditions. For one thing, it's much more expensive getting games approved by the FDA than it is to develop the games themselves -- an economic reversal of the typical pharma drug development model.

As a consequence, it would be very easy for competitors to develop therapeutic games of their own and get them approved by the FDA, which is likely to consider such games as medical devices (they are not consumed by patients). I believe that the way FDA approves medical devices makes it easier for competitors to get similar games approved without having to finance new clinical trials. "Me too" game developers can use existing clinical data paid for by the "innovator" company as evidence of safety and efficacy.

Then there would be "over the counter" competition from games that do not have to be approved by the FDA as long as they are not marketed as being effective in treating a disease like Alzheimer's (the marketers, however, can say things like "helps improve cognitive ability").

Hey, I'm sorry to break your bubble -- ie, hype -- about the potential of gamification for the pharmaceutical industry in so far as treatment modality goes. It's not that games may not be effective in the treatment of certain medical conditions -- they could be. My point is that it is unlikely that traditional pharma companies will develop games for that purpose for the reasons cited above and in previous posts. That's my opinion and I'm sticking to it!

Phil Disclosure: Mickelson is a Serial Undisclosed Celebrity Endorser

Today, while reading an article about 5 Guys Burgers ("All in the Family") in the August 2012 issue of Forbes Magazine, I came across a reference to Phil Mickelson. In 2010, Mickelson gave a glowing, unprompted endorsement of Five Guys Burgers during a press conference at The Players Championship.

"What I’ve done the last five days, go to Five Guys Burgers. That place is so good. I can’t stop going there. This will be my sixth day in a row. I grew up on In-n-Out. I thought that was the best burger until I had Five Guys. That is hands down the best burger I’ve ever had" (see story here).

A few days later, fellow golfer Stewart Cink, a big fan of In-N-Out, directed this tweet at AP golf writer Doug Ferguson: “Keep in mind, PM owns SoCal rights to FiveGuys. Biased argument?”

[Keep in mind that Cink may shill for In-N-Out - his Twitter profile shows him eating an In-N-Out burger and fires.]

Cink was correct - Mickelson was biased. As reported on CNBC, Gaylord Sports Management, which represents Mickelson, confirmed that Mickelson was in fact part of a group that has purchased the rights for Five Guys franchises in Orange County.

A few months later, during the 2010 PGA Championship, Mickelson again made an "unsolicited" endorsement. This time, it was for ENBREL, the Amgen/Pfizer drug inicated for the treatment of psoriatic arthritis.

The subtitle to a NowPublic article titled "Phil Mickelson Arthritis: Will Play At PGA Whistling Straights", stated "Phil Mickelson Has Psoriatic Arthritis - Uses Enbrel To Help Manage Condition." The article (here) includes this quote from Mickelson: "I have no aches and pains. My back feels great. I feel stronger and more flexible than I've ever been."

At the time, I asked "Is Phil Mickelson Shilling for Enbrel?"

Well, the jury is out on whether or not Mickelson was a paid ENBREL celebrity endorser at the time he made that statement. But in a manner similar to his Five Guys Burgers outing by social media, it was later revealed that Mickelson was indeed a paid celebrity spokesperson for ENBREL (see "Phil Mickelson 'Opens Up' to Arthritis Today Magazine"). The Arthritis Today article claims that Mickelson "entered into a partnership with Amgen-Pfizer, an Arthritis Foundation sponsor, in November, 2010." Also see "Amgen Blows Its Marketing Budget on Phil Mickelson Campaign" for the Amgen press release announcing the deal.

As soon as Phil became a PAID spokesperson for ENBREL, he could not say these things because he became an extension of the brand and subject to FDA regulations. But at the time he said the above, I suspect he was giving his future benefactors a freebie! We don't know how long the negotiations were going on before the deal was signed, but this story could have been arranged to seal the deal.

BTW, my sons think Five Guys Burgers are "epic." They ate at a Five Guys joint every week while at Penn Statd. Of course, they are not paid by Five Guys nor do they own a Five Guys franchise.

So, I'm not saying that Mickelson lied when he said a Five Guys burger was "the best burger I’ve ever had" nor when he said he feels "stronger and more flexible than I've ever been" after taking ENBREL.

My concern is a celebrity who promotes a drug having dangerous side effects without revealing that he may have a financial interest in the product. When Mickelson first made his statements about ENBREL he may or may not have technically signed a contract, but it was obviously meant to get the work -- a demonstration of what he could do. Now that he is featured on ENBREL TV ads, everyone knows he is a paid spokesperson. I have no problem with that, especially that now his commercial speech is regulated by the FDA and he can no longer make outlandish statements.

UPDATE (8.16/2012): In a personal communication, a reader said: "I had to laugh when several times I thought I noticed Phil dropping a right hand wedge into his bag during the TV commercial. But look closely, it's true..." Phil is left-handed, so I guess the director of the commercial used his own clubs as props!

War on Counterfeit/Illegal Drugs Hobbled by Same Demons as Real War

Pfizer Intelligence Uncovers $200 of Counterfeit Viagra In Manila Raid!

"Armed with a tip from pharmaceutical company Pfizer Inc., several dozen government investigators carried out a series of rapid fire raids one day last month on what were supposed to be the key suppliers of counterfeit drugs in the city [Manila]," reports the Wall Street Journal (read the story here).

"The net result of the raids, touted beforehand as likely to be one of the largest counterfeit drug busts in the city this year, was $200 worth of fake Viagra, Pfizer's erectile-dysfunction drug."

This intelligence gaffe reminds me of the Bush-era Iraqi weapons of mass destruction intelligence gaffe that propelled us to war in Iraq. I'm wondering if the "war on counterfeit drugs" is similarly based on faulty intelligence?

Another similarity between these two types of war is the unbridled optimism expressed by those in charge. "I think we are making a dent in the problem, but it's a slow process," said Scott Davis, senior director for global security in the Asia Pacific for Pfizer and a former special agent for U.S. Customs. Smells or sounds like victory, but it's no where near actual victory.

Here's yet another analogy: the war on counterfeit (or illegal) drugs seems to be as hobbled by rampant corruption of officials as is the war in Afganistan (or Iraq). In the case of the Manila raid, an owner of a couple of the target warehouses "bragged that he knew the NBI's [the Philippine's National Bureau of Investigation; i.e., the country's FBI] lead investigator on the counterfeit drug case and the deputy director who authorized the raid." After the raid turned up practically nothing, "the owner and the government agents walked a block away to lunch at Maxim's Tea House, a Chinese restaurant, according to people close to the investigation." That lunch probably cost more than $200!

It was interesting that the raiders found what they thought was counterfeit Cialis -- an ED drug marketed by Eli Lilly. Unfortunately, they did not have a search warrant for that illegal product, so no one was arrested.

It appears that Pfizer and Lilly did not share their intelligence data in this case, otherwise the NBI could have had a more inclusive search warrant.

This begs the question: Is the drug industry working together as allies in the war on counterfeit/illegal drugs? Are they sharing intelligence? Or is this also "proprietary" information that each company wants to keep close to its vest?

Congress Gives FDA 2 Years to Issue Social Media Guidance. All Bark, No Bite.

A little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act" (aka PDUFA, pdf), which was signed into law by president Obama on July 10, 2012, simply states:

SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE INTERNET.

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.

Does that mean the FDA will deliver? If not, it wouldn't be the first time that a government agency missed deadlines imposed by Congress.

Usually, Congress specifies that regulatory agencies must issue regulations that spell out how to comply with the laws it passes. Regulations, therefore carry the weight of law. FDA Guidance (guidelines), however, is just FDA's current thinking on a topic. "It does not create or confer any rights for or on any person and does not operate to bind FDA or the public."

So, if FDA misses the deadline set by PDUFA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

The only thing interesting about this provision of the PDUFA act is why it was included and who lobbied to have it included? It couldn't have been Pfizer (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"), but it could have been PhRMA (see "PhRMA Statement on FDA Social Media Guidance Delay").

“We do things at Pfizer that are best for shareholders of Pfizer." You Gotta Problem with That?

I can't believe a Pfizer "spokesperson" (Corporate Secretary and Chief Governance Counsel, Matthew Lepore) said:

“We do things at Pfizer that are best for shareholders of Pfizer" 

when defending Pfizer's continued financial support of Heartland Institute, an organization whose president Joe Bast claimed that the public health community has a campaign to "demonize smokers" based on "junk science" (find the story here: "Pfizer Refuses To Pull Funding From Anti-Science Front Group").

Among the books authored by Joe Bast is "Please Don’t Poop in My Salad (and other essays opposing the war against smoking)" (see his 2008 resume here).

First of all, it's shameful for a drug company that on one hand promotes campaigns to help people quit smoking (eg, CHANTIX direct-to-consumer commercials) while on the other hand supports an organization that believes anti-smoking campaigns are based on "junk science." How does that resonate with people who are taking CHANTIX?

Secondly, doesn't Mr. Lepore know that Pfizer's trademarked slogan is "Working Together for a Healthier World" and NOT "Working Together for a Profitable Investor"?

Lepore also stated that Pfizer "isn’t concerned" by the decisions of Eli Lilly, GlaxoSmithKline, and Bayer, to disassociate themselves with Heartland. "We can't be very knee jerk on every issue that is brought to our attention," said Marc Scarduffa, Vice President, Government Relations & Public Affairs.

Which reminds me of a typical New Yorker conversation ender: "You gotta problem with that?"

Can Pharma Cure Alzheimer's Disease? A Pfizer Pre-Launch Multichannel Marketing Case Study

Last month I quipped on this blog that "Pfizer's Social Media Initiatives are Getting Old." Actually, that was a review of Pfizer's new "Get Old" initiative, which Pfizer says is a "first-of-its-kind online community" where people can "get and share information, add to the dialogue and contribute to the growing body of knowledge about this important topic."

In that post, I suggested that Pfizer's real goal was to court advocacy groups such as the Alzheimer’s Association in advance of the announcement of results from an Alzheimer clinical trial of its drug ddsigned to treat the disease.

Just a couple of days ago, on the CBS Evening News, I saw an interview of Rae Lyn Burke, "An Alzheimer's researcher who is also a patient." Ms. Burke is participating in a clinical trial of bapineuzumab (bap-ih-NOOZ-uh-mab), a drug with a funny, Irani-sounding name. Turns out that bapineuzumab is a Pfizer/Johnson and Johnson drug.

Ms. Burke's participation in an Alzheimer clinical trial is old news. According to an August, 2011, San Francisco Chronicle story (here), "Burke worked on some of the initial research into bapineuzumab" (her LinkedIn profile indicates that she is "senior Director at SRI International," a CRO that is likely running the Pfizer Alzheimer clinical trial).

The 2011 story also revealed that "Burke has been in the trial for almost two years, and should find out shortly whether she's been receiving the active drug or a placebo. If she's on the placebo, she intends to switch to the active drug as soon as possible.

She obviously was in the bapineuzumab arm of the study, or switched, because in her recent CBS interview she said that she taking the drug and it was "slowing the decline, but I don't think it's making me better." That's too bad.

Is this all part of Pfizer's multichannel marketing of bapineuzumab prior to its approval by the FDA (if indeed it ever does get approval)?

It's no coincidence that Burke's story was resurrected shortly before results from key studies of two Alzheimer's drugs -- including bapineuzumab -- are to be released. But the journalism stinks: the CBS Evening News story is practically the same, word-for-word as the 2011 San Francisco Chronicle piece cited above. Maybe CBS owns the San Francisco Chronicle or maybe it's becoming more like a blog rather than a primary source of news.

There are also stories in newspapers about these trials, such as this one from the Mercury News: "Alzheimer's drugs could be pharmaceutical industry's last-gasp efforts to cure disease" and this one from the Denver post: "Alzheimer's cure may lie in three drug (sic) tested over past decade." Both of these stories are based on the same AP story, which does NOT mention "cure" but says the drugs are meant to "slow the course of Alzheimer's disease."

I always find it odd that reporters often overstate the efficacy of drugs, sometimes in collusion with drug companies (see, for, example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons"). Perhaps the local news reporters were influenced to use the word "cure" by Pfizer, JNJ, Lilly, and/or Baxter PR parrot trainers?

As I mentioned in my "Get Old" post, institutional investors doubt that treatments for Alzheimer's disease being developed by Pfizer (and Lilly) will "achieve the main goals of their ongoing late-stage trials." Those goals certainly are NOT to CURE Alzheimer's, but only "aim to clear the sticky plaque gumming up patients' brains."

"Everybody in the field is probably holding their breath that there is something positive to come out of these trials," said Dr. Ronald Petersen, director of the Mayo Clinic's Alzheimer's Disease Research Center. "It may not be a home run" in terms of improving memory and cognition, but if brain imaging or spinal fluid tests show the drugs are hitting their target, "they will be regarded as successes," he said.

Next week, at the 4th Annual Social Communications & Healthcare: Case Studies and Roundtables confernce in NYC, I hope to discuss this with Pfizer's Andrew Topen (VP of Global Media Relations and Digital Communications), Caroline Roan (VP of Corporate Responsibility and Reputation), and/or  Bob Libbey (Senior Director of Global Colleague Communications). These exceutives led the GetOld.com site project and will present the Get Old Case study ("Pfizer Starts a Conversation about Aging") at the conference.

NOTE: Pharma Marketing News is aMedia Partner for this conference. You can get a $20 discount off registration if you have the secret word, which you can find here.