Showing posts with label Disease Mongering. Show all posts
Showing posts with label Disease Mongering. Show all posts

Wednesday, April 03, 2013

Nalts Has Low T! Asks Internet for a Diagnosis Based on His Brain MRI Images. Isn't There an App for That?

Nalts (aka "ADHD Boy", aka Kevin Nalty, Marketing Strategist, former Merck/Janssen-Cilag employee) posted a new YouTube video of his brain -- which includes a series of MRI scans. It seems he has "Low T" (low testosterone) and his doctor recommended the scan to see if his Low T is caused by a "pituitary issue." I hope he is OK and just growing old like the rest of us.

As Nalts himself admits, he has no privacy when it comes to his health issues. I've blogged about his ADHD years ago (see "ADHD Boy").

His brain scan video is his latest revelation about his health-related problems. In the video Nalts asks for some "wisdom of the crowd" to help him/his doctor? interpret the image and arrive at some kind of diagnosis. Here's the video -- see if you can help:


"Low T" is a phrase invented by AbbVie, which markets Androgel, a "hormone replacement" gel for men. AbbVie's “Drive for Five” campaign urges men to know their testosterone levels, in addition to lipid, BP, blood sugar and PSA numbers. On the website (http://www.driveforfive.com; "Mens Health | Learn about 5 risks to mens health") is an animated "gear box" that shifts from high cholesterol (first gear) to high blood pressure (second gear) to high blood sugar (third gear) to high PSA (four gear) and, finally, to low testosterone (fifth gear). AbbVie's "Low T" agencies are Digitas Health for consumer ads and AbelsonTaylor for professional ads ; More...

The driveforfive.com website encourages men not to be "embarrassed to talk to your doctor about any health problems you may be having, such as:
  • Reduced sex drive
  • Problems during sexual activity
  • Feelings of sadness
  • Bladder or bowel control
  • Weight gain
  • Drug abuse
I don't know which, if any, of these symptoms drove Nalts to his doctor. What I do know is that Nalts is a father of 4 children, is a comedian, has male-pattern baldness, and is pretty thin -- all of which do not fit the symptom profile promoted by AbbVie. I'm not sure, however, if he currently has problems of a sexual nature or if he is abusing drugs (although he once said, in jest, "Not taking drugs is like not drinking water when you are thirsty").

Perhaps his doctor just routinely measures testosterone levels in men of a certain age because AbbVie sales reps suggested he/she do that as part of the "Drive for Five" campaign.

Speaking of Marketing of Low T, I will interview Adriane Fugh-Berman, MD, Associate Professor at Georgetown University Medical Center and Director of PharmedOut, about this subject in an upcoming Pharma Marketing Talk show.

This show is a live streaming audio podcast that airs on Thursday, April 25, 2013, at 2:00 PM (Eastern US). You can listen live or to the archived podcast afterward here.

We will discuss how the marketing of Low T drugs uses ghostwriting, celebrities, symptom quizzes, and numbers to convince men and physicians that "low testosterone" is a medical condition that should be treated.

I invite Nalts to participate in the discussion and tell us more about his experience and possibly debate the issues with Dr. Fugh-Berman. Topics/Questions for discussion include:
  • How does the marketing of Androgel and other testosterone gels and patches use ghostwriting, celebrities, symptom quizzes, and numbers to convince men and physicians that "low testosterone" is a medical condition that should be treated?
  • Do you see this as a problem akin to "disease mongering?" What's the harm in making more men aware of "low testosterone" and urging them to treat it?
  • Are the same tactics used for other products?
  • How do direct-to-consumer (DTC) ads for these products differ from professional ads aimed at physicians?

Wednesday, October 03, 2012

Shane Victorino: Adult ADHD Poster Boy

Adult ADHD (attention deficit/hyperactivity disorder) is the "next big thing" for pharma companies like Shire, which markets Vyvanse for the treatment of ADHD in adults. So says the author of a Salon article titled "Big Pharma’s newest invention: Adult ADHD."
“Immature adult market continues to offer greatest commercial potential,” read a 2008 press release to the pharmaceutical industry from the market research agency Datamonitor: “Estimated to be twice the size of the pediatric ADHD population, the highly prevalent, yet largely untapped, adult ADHD population continues to represent an attractive niche to target.”
So who might consider themselves part of this “untapped” market?

Well, former Philadelphia Phillies center fielder Shane Victorino for one. The "Flyin' Hawaiian" is now an adult ADHD celebrity spokesperson appearing in magazine ads like the one shown below and in video testimonials like the one you can find on ShanesStory.com.


If you talk to people in the know, Victorino is an ideal adult ADHD "poster boy." I've heard that Victorino was a mile-a-minute talker and often people around him wished he'd shut up. In a Shire-sponsored YouTube video, Victorino himself admits "always interrupting" his teammates and having problems focusing.

Interestingly, Victorino doesn't mention Vyvanse. It's unclear, therefore, if he benefited from Shire's drug, which entered the market in 2007, about 8 years into Victorino's major league career and about the time that Victorino became a starting player for the Phillies.

So it's unclear if Vyvanse -- or any other medication -- helped Victorino play ball as well as he did for the Phillies. Some have speculated, however, that his constant talking and interruption of teammates was one reason why the Phillies traded him. Could the trade be part of a devious Phillies plot to insert a disruption agent within the ranks of a rival team?

I'm just kidding, of course. Like many Phillies fans, I like Victorino and wish him the best.

Unlike some other pharma-paid celebrities, Victorino is not promoting a brand of drug, but promoting awareness of a medical condition. Some people -- like the Salon article author -- claim that ADHD awareness marketing is a form of "disease mongering," which causes more people to be diagnosed with the condition than is necessary. But that's a whole other issue that I don't have time to get into now. You can read about disease mongering here.

Tuesday, November 08, 2011

Your Wife, Your Choice - Diapers or Detrol (now Toviaz)?

Pfizer's @pfizer_news Twitter account just posted this tweet:
"Toviaz top-line primary endpoint results positive in overactive bladder study of nocturnal urinary urgency http://t.co/OU60l6oZ" (see here). 
The link is to a press release that reports the results of a study that purports to show that Toviaz (a reformulation of off-patent Detrol) is "statistically significantly superior to placebo" in treating OAB (Over Active Bladder). The "statistically significantly superior" results were "based on patient self-reporting," which is a very subjective measure of efficacy to say the least.

OAB is one of those "medical conditions" that has been refurbished by the drug industry so that more people -- especially women -- can believe they have a problem requiring treatment by a pill rather than by some other, less invasive, means. I wrote about this before -- see "Overactive Bladder: 'Pharmacia instrumental in creating new disease' says Former VP." Pharmacia was purchased by Pfizer after that post was made.

An anonymous commenter to that post said:
"In the case of OAB, Pharmacia (and later Pfizer and others) provided an acceptable name for the condition, increased awareness, and provided access to effective treatment for a large group of patients (women especially) suffering a hugely difficult condition. Your wife, your choice - diapers or Detrol?"
I thought the last sentence was worth immortalizing in the title of this post because it is said that OAB is one of those conditions that "women especially" suffer from.

The Pfizer press release claims that "approximately 33 million Americans are estimated to suffer from overactive bladder symptoms." It doesn't say how many of these Americans are women, but the Toviaz Web site features a woman posing as a patient ("Not an actual patient") as in this banner:


Yesterday, I asked "Do Women Take More Drugs Than Men Because They Need To or Because They Are Targeted by DTC Advertising?" (see here). Toviaz ads (eg, the Toviaz.com Web site) demonstrate how women are targeted by direct-to-consumer (DTC) advertisers. As I mentioned in yesterday's post, I plan to discuss this in an upcoming Pharma Marketing Talk LIVE podcast discussion tomorrow (see "How to Score With Women (as a Marketer) via Social Media").

One other thing I have to say about the @pfizer_news tweet is that it is an example of a branded tweet that may not comply with FDA regulations because it mentions a brand name drug plus its indication but does not include any "fair balance" (ie, major side effect information) as required by law.

Most pharma social media initiatives such as company blogs and twitter accounts (including @pfizer_news) are managed by corporate communications people who are increasingly taking on the role of brand marketers. These people tend to think of themselves as outside of FDA's purview. Consequently, Pfizer may claim that the Toviaz-branded tweet is notice of a press release, not advertising, and that the press release contains the necessary fair balance (albeit one click away).

In the post about OAB mentioned above, I included slides from a Pharmacia VP that demonstrate the importance of PR and the media in "creating a new disease." One slide said "Drive potential patients to physician offices by using DTC and PR with symptom recognition." Another slide (see below) shows that the Media are an important component in creating consumer demand:


Thursday, February 18, 2010

A Snarky Look at Sneaky Marketing Tactics Pharma Hasn't Avoided

My friend Jonathan Richman (@jonmrich) often sees the pharma marketing glass half full, whereas I often see it half empty. It's just the way we are wired. The goal, however, is the same -- improve pharma marketing.

Jonathan likes lists. In a recent article entitled "10 sneaky marketing tactics you need to avoid" published on iMedia Connection, Jonathan lists some dubious marketing tactics that companies should avoid. After just a cursory reading of his list, it is obvious to me that pharmaceutical marketers have not been very good at avoiding most of these and other sneaky tactics.

#1 Sneaky Tactic Pharma Has Not Avoided: "AstroTurfing"

"Simply put," says Richman, "AstroTurfing is when a company or group creates a campaign designed to look like a grassroots consumer movement when, in fact, it's completely artificial."

Some time ago, I pointed out one instance of "astroturfing" in the pharma realm: the RLS Foundation. The Restless Leg Syndrome (RLS) Foundation -- a US patient organization -- has very close ties to GSK -- a UK-based company that markets ReQuip for treatment of (RLS). In fact, I believe that the RLS Foundation was established by GSK. Here are some interesting factoids that support my thesis (see "Restless Pharma Marketing", for more details):
  • GSK is a Gold Corporate Sponsor of the RLS Foundation, which means GSK has given the foundation a good chunk of change;
  • at least one member of the Foundation's Medical Advisory Board has financial ties to a pharmaceutical company (GSK) with a treatment for RLS;
  • the PR activity of the organization seems to have picked up right when that company's drug (ReQuip) hit the market;
  • the first RLS Foundation Science Award went to Ronald L. Krall, MD, Senior VP of Worldwide Development at GSK;
  • Dr. Richard Allen, a member of the RLS Foundation's Medical Advisory Board, had the "pleasure" of "collaborating" with GSK to do studies supporting the data on the prevalence of RLS in the US and in Europe;
  • the color scheme of the RLS Foundation's Web site matches that of the Requip product site.
#2 Sneaky Tactic Pharma Has Not Avoided: Spam and violation of privacy rights

Jonathan calls this "Lucky guess (aka, we were 'smart' enough to acquire your email address, so we're sending you stuff)." This falls under the heading of contacting someone without their permission. This actually happened to me when I participated in a focus group for erectile dysfunction. I received a phone call from the agency doing the research because I requested information from the Levitra Web site -- I did not give my phone number, but gave my address so they could send me the information. The researchers were "smart enough" to obtain my phone number from my address and bingo! "Lucky guess!" Read all about my experience in the Pharma Marketing Blog post "Market Research: Privacy Matters."

#3 Sneaky Tactic Pharma Has Not Avoided: Anonymous tidying (aka, we fix what we don't like and hope you don't find out)"

"If you try to cover up your identity online, people will find out. Always," says Richman.

Oh boy! Where to start here? You can find some good examples of this sneaky tactic in my "Web 2.0 Pharma Marketing Tricks for Dummies" (click here and use code 'free68' to get it FREE). In there you'll find out how pharma marketers or their agents pose as consumers on social networks, alter Wikipedia entries about drug information, and lots more sneaky stuff.

#4 Sneaky Tactic Pharma Has Not Avoided: A little off the top (aka, we reject reality and substitute our own stylized version)

Pharma marketers routinely do this by overestimating the number of people who MAY have the medical condition that the drug is approved to treat. Sometimes, it is claimed, pharma marketers create diseases where none really exists. This is called "disease mongering." You can read about that in this Pharma Marketing News article: "Disease Mongering: When Is the Line Crossed?" I also have documented this "sneaky tactic" a number of times here on Pharma Marketing Blog. See, for example, "40over40: Lilly's DTC ED Awareness Campaign in the UK" and, more recently, "Danica Patrick: NASCAR Driver, Super Model, Superbowl Lingerie Ad Model, & COPD Spokesperson All Rolled Into one!"

I am not going to address the remaining 6 "sneaky tactics" on Richman's list; I need to take my morning shower, especially after revisiting all these sneaky tactics. Some of the tactics probably don't apply to pharma because they are used to promote consumer products in ways that pharma has not yet mastered. Or it is impossible to know if these tactics have actually been employed. Also, there are many other "sneaky tactics" that Richman doesn't mention, but which are employed by pharma marketers (see "Dummies").

Sunday, April 05, 2009

Overactive Bladder: "Pharmacia instrumental in creating new disease" says Former VP

I just received a link to an old Powerpoint (PPT) presentation that was featured at an October, 2002, Pharmaceutical Marketing Research Group (PMRG) conference. The presentation was entitled "Positioning Detrol (Creating a Disease)" and the presenter was Neil Wolf who, at the time, was Group Vice President at Pharmacia, the drug company purchased by Pfizer. As you may know, Pfizer is preparing Toviaz, a follow-on drug to Detrol, for marketing (see "Detrol v. Toviaz: Marketing Replaces Innovation at Pfizer!").

The presentation outlines the strategies used to convert a "niche product into a Mass Marketing Opportunity." Download it here.

I was gratified to get my hands on this PPT because I remembered being present at the 2002 meeting and how shocked I was that a pharmaceutical VP would actually be so transparent in discussing how "overactive bladder" was a "new" disease that he and his company created specifically to increase the sales of Detrol! Often, I wished I had a copy of that presentation to prove that I wasn't imagining things and now here it is.

The introductory notes state:
How many have seen
How many have heard of overactive bladder?
How many have overactive bladder???

Overactive Bladder now a lexicon in American culture
-cocktail parties / media / sitcoms / talk shows

Most importantly, routinely discussed between patients and their physicians
Not the case 4 years ago

Pharmacia instrumental in creating new disease
-improving lives of millions around world
Some critics of the pharmaceutical industry say that overactive bladder (OAB) is an example of "disease mongering," a term that was coined by the late journalist Lynn Payer to describe what she saw as the confluence of interests by some doctors, drug companies, patient advocacy groups and media in exaggerating the severity of illness and the ability of drugs to "cure" them (see "Disease Mongering -- Is it real or not?").

I believe this presentation is a classic "disease mongering" case study.

Slide #20 shows how by creating a "new" disease, the potential market for Detrol could be increased 2.7-fold!


Slide #22 states the "Critical Success Factors" for the Detrol launch in the US:

This is now the classic formula for creating greater demand for an Rx product than would normally be the case. As you can see, "education" of PCPs (primary care physicians) is a critical component as is DTC and PR (public relations).
NOTE: Influencing Prescribers
The American Medical Women's Association (AMWA), which is cited as a resource on the Detrol product Website, is currently promoting an "Overactive Bladder Initiative," which includes a "comprehensive continuing medical education curriculum" that provides "primary care providers with the latest discoveries concerning etiology, epidemiology and treatment of urinary incontinence, with particular emphasis on practical management strategies of overactive bladder, particularly as it affects women." AMWA lists Abbott, Novartis, Astrazeneca, and Wyeth (recently purchased by Pfizer) as corporate sponsors.
Slide #30 in the deck clearly shows that Pharmacia understood the need to achieve the "confluence of interests by some doctors, drug companies, patient advocacy groups and media" as well as REGULATORY people to achieve its aims:


To get payors (ie, insurance companies) to place Detrol on their formularies and pay for OAB treatments, Pharmacia convinced them that OAB was "a serious medical condition, not just a 'lifestyle' disorder" citing "Skin and soft tissue infection," "Falls and fractures," "UTIs," and "Significant co-morbidity with depression and sleep disorders" (slide #39).

Interestingly, none of these "serious" conditions was ever mentioned in the DTC marketing of Detrol. That might be just too much education for consumers to swallow!

Continue the discussion via Twitter...

--------------
Listen to this WHYY radio segment, which aired Monday, April 20th, 2009:

"Inventing a disease"

Tuesday, November 25, 2008

"Making A Killing:" Scientology Video Blasts the Pyschiatry-Drug Industry-FDA Complex!

I stumbled across "Making A Killing" -- a new video produced by the Citizens Commission on Human Rights (CCHR), which is a non-profit organization founded in 1969 by the Church of Scientology -- after reading a post by Howard Brody, medical ethicist author of the Hooked: Ethics, Medicine, and Pharma blog.

Brody wrote a "public service announcement" claiming that he was misled into being interviewed for the video that demonstrates the "underhanded and dishonest methods used by Scientology to attack the practice of psychiatry and the use of psychotropic medications."

Brody ended by saying "I regret very much allowing myself to have become involved in this project and would like it to be known that I disown and disapprove of the final product and the way that it has been disseminated."

Of course, after reading Brody's account, I just HAD to view the 95-minute video, which is available in ten segments via YouTube (start here). Currently, this video has only been viewed by a few hundred people, but I suspect many more people will be viewing it after it is talked about in the Pharma Blogosphere, starting with Brody's attempt to distance himself from the project.

The description the video states:
“Psychotropic drugs. It’s the story of big money–drugs that fuel a $330 billion psychiatric industry, without a single cure. The cost in human terms is even greater–these drugs now kill an estimated 42,000 people every year. And the death count keeps rising. Containing more than 175 interviews with lawyers, mental health experts, the families of victims and the survivors themselves, this riveting documentary rips the mask off psychotropic drugging and exposes a brutal but well-entrenched money-making machine.”
Obviously, CCHR makes no bones about being vehemently anti-psychiatry and describes the many ways that psychiatrists and the FDA are in cahoots with the drug industry to get psychotropic drugs approved and prescribed based on very little evidence. One claim the video makes is that many clinical trials of these drugs only involve treatment for 8 to 12 weeks, whereas patients may take these drugs for years.

The video scans a few published articles to prove this point, but I decided to check for myself. I chose to look at drug trials for Cymbalta, which was approved by the FDA for the treatment of "Generalized Anxiety Disorder" (GAD) -- one of those "diseases" that the video claims is not a disease at all. I picked a study at random from the Lilly Clinical Trial Registry site and found trial 5075 (HMBR), a phase III study. Sure enough, when you look at the report, the duration of treatment was 9 weeks, during which time there were no deaths reported.

On the basis of these kinds of trials, the drug industry is completely truthful when they say that clinical studies show no evidence that these drugs cause an increase in suicides, which is what CCHR and many relatives of people who have committed suicide when on these drugs claim. So, we will never know if "psychotropic drugs now kill an estimated 42,000 people every year" as the video says. But that number is just thrown in by CCHR for dramatic effect and you may call it "underhanded and dishonest," but if you can get beyond the rhetoric, you'll have to admit that the video makes some very valid points worth considering.

For example, the video points out that many mental disorders that are catalogued in the DSM as "diseases" are not really diseases at all. They are just disorders or some common, everyday behaviors we all endure that have been "voted" as diseases by psychiatrists who profit from drug industry money and from writing prescriptions. Many of the experts interviewed admit that there are no physical, objective tests for mental illnesses. The Cymbalta study I cited above, for example, uses a HAMA score -- a subjective rating test where patients answer questions about how they feel -- to determine effectiveness of the treatment.

I'm not going to jump up and down on my couch to defend the Church of Scientology's position that all mental diseases are fictitious and do not require drug treatment. But there does seem to be scant scientific evidence to support the use of admittedly dangerous drugs for such iffy conditions as GAD (see "eGAD! How I Learned to Stop Worrying and Love Cymbalta!").

However, we don't have to look much further than the news reports of the last few days to know that psychiatrists are too cozy with the drug industry. Just yesterday, Ed Silverman of Pharmalot reported that Harvard University’s Joseph Biederman -- a world-renowned child psychiatrist also mentioned in the CCHR video -- "had earned far more money from drugmakers than he had reported to the school" and that "e-mails and internal Johnson & Johnson documents made public in a court filing reveal Biederman pushed the drugmaker to fund a research center at Massachusetts General Hospital, and the point was 'to move forward the commercial goals of J&J,' according to the documents, The New York Times reports. The documents also show J&J wrote a draft summary of a study that Biederman was said to author" (see "Harvard’s Biederman And His Ties To J&J")

Silverman also reported this story a few days ago:
"Last May, National Public Radio talk-show host Fred Goodwin was, himself, the subject of a great deal of chatter. An episode of his program, “The Infinite Mind,” which is heard on 300 NPR stations, featured three experts who discussed the controversial link between antidepressants and suicide. And all four, including Goodwin, declared that worries about the drugs have been overblown.

"But there was a catch: Goodwin never pointed out that all three guests had ties to pharma, or that the show received 'unrestricted' from drugmakers, including Lilly, which sells Prozac and Cymbalta. The segment, by the way, aired just two months after UK regulators concluded a four-year investigation of Glaxo's Paxil and found the drugmaker had been aware since 1998 that its pill was associated with a higher risk of suicidal behavior in adolescents." (See "Talk Is Not Cheap: NPR Host Has Ties To Pharma").
Last week, the Carlat Psychiatry Blog reported "an FDA advisory committee has accused the agency of doing too little to warn physicians about the dangers of prescribing newer antipsychotics to children" (see here).

Speaking of FDA Advisory Committees, CCHR points out what we've all been saying for years: these committees are loaded with conflicts of interests -- physicians who have ties to the drug industry who recommend drugs for approval.

Neither you nor I may want to further the goals of the Church of Scientology, but it has produced an effective video that is an indictment of the drug industry's too close ties with psychiatrists. I urge you to view this video and get beyond the hype to objectively evaluate some of the issues it raises. It made me rethink a few things.

Friday, June 27, 2008

Battered Woman Imagery in Pfizer's New Fibromyalgia Ad

Pfizer has recently upped the stakes in its campaign to depict fibromyalgia as a "real" medical condition.

In an non-branded "disease awareness" TV ad that I saw last night, this point was hammered home by images of a woman showing black and blue bruises over her body. She says something like "Maybe if people saw me this way, they will believe that fibromyalgia is a real medical condition."

What I saw were disturbing images reminiscent of battered woman syndrome. The whole thing smacked of desperation on Pfizer's part to sell more drugs and represents DTC advertising sinking to a new low in exploiting women's fears!

I was not able to capture an image of the woman from my TV, so I am using the image above left that I found at the Medical Advocates/Battered Women web site. It accurately conveys the message that Pfizer put on the screen. (If you can get an actual screen shot of the ad, please send it to me at johnmack@virsci.com).

The ad urges viewers to visit the FibroCenter Web site where they can find information about a treatment option; ie, Lyrica, Pfizer's drug approved for the treatment of fibromyalgia.

Perhaps Pfizer is getting desperate to sell more Lyrica in the face of criticisms that fibromyalgia is not a real medical condition. The cartoon on the right from the Dry Bones Blog is a case in point.

Adverse Event Reporting Be Damned! Tell Us Your Story!

Meanwhile, if you visit the FibroCenter Web site you may be surprised to find that Pfizer is soliciting stories from patients (note: the same form can be accessed from the Lyrica.com site):

"Are you living with fibromyalgia? Would you be willing to share your story with others, so that they may learn from your experience? If so, please answer a few short questions to get started ..." (see here).

There are several multiple choice questions, but what shocks me is the box for an open-ended response with the instruction: "Please use this space to share your story about living with fibromyalgia. Please limit your story to 3000 characters or less. (Approximately 500 words.)"

WOW!

What an opportunity to collect ADVERSE EVENTS, which Pfizer must then submit to the FDA. I always thought -- and pharma people have always said -- that one of the reasons the industry is shunning Web 2.0 social network sites is the possibility that they would then have to report a slew of adverse events to the FDA. And who wants that? But here is Pfizer doing just that! If nothing else, this can be used as a case study to counteract the main argument pharma has used against social media engagement.

Pfizer also collects personal information that will uniquely identify people who "tell their stories": "In case it is selected for publishing on the site, we will need to collect your name, city, state, phone number, as well as your e-mail address so that we may notify you. By submitting your information, you agree that it will be governed by the Consent and Release statement below."

The consent form also admits that Pfizer is collecting personal medical information: "I grant my consent to use my name, biographical data and relevant medical history by Pfizer Inc in any Permitted Use identified below."

Pfizer, of course, hopes to collect contact information about patients so they can send them information about LYRICA (it says it will do that in the consent form). But it may be collecting more than it bargained for.

For example, Pfizer may collect stories such as the following, which I found in one of the first comments to the Dry Bones blog post I cited above:
"Having put up with Fibro since I was 25 (18 years ago)- I can tell you it exists. I loved the toon! I won't be taking Lyrica though, I keep it under control through weight control, light exercise and relying on G-d, "for man shall not live by bread alone, but by every word that proceeds from His mouth."
OK, "G_d" may not be Lyrica's #1 competitor, but life style changes may be. However, you won't find THAT option in the main menu at the FibroCenter Web site -- "A Community of Education, Support and Understanding for People With Fibromyalgia." You'll have to dig deeper.

Tuesday, February 05, 2008

Making Fun of Pharma Marketing is Easy

I've just returned from a few days vacation on the beach in Sunny Isles, Florida and I haven't yet recovered from the Motivational Deficiency Disorder (MDD) symptoms that resulted!

Haven't heard about MDD? You might want to take a look at the following video produced by the folks at Consumers International (CI) . The video explains what MDD is, how it's treated, and -- most importantly -- how one pharmaceutical company markets Strivor, its new MDD treatment:



I particularly like the part about 4 minutes into this video where the good doctor talks about clinical trial results on sloths.
"You've seen nothing," says the doctor who invented Strivor, "until you've seen a sloth that's motivated, I'll tell you!"
Ba Boom!

Ha, Ha, Ha.

The anti-pharma marketing shenanigans of CI have only recently caught the attention of blogs like the WSJ Health Blog (see "Striving for an Antidote to Drug Marketing") and Pharmalot (see "Do You Have Motivational Deficiency Disorder?").

This MDD spoof may be new to some bloggers, but I highlighted the first MDD video spoof back in January, 2007 (see my post "Disease Mongering and Pharma Credibility"). I thought this first video was quite well done. Some of the recent MDD videos produced by this group, however, merely remix scenes or recreate similar scenes. The latest iteration features a woman sufferer of MDD (click here to see that video).

Frankly, I do not see any women sufferers of MDD, which I believe mostly affects young men between the ages of 14 and 28. The messy surroundings depicted in the video look EXACTLY like my son's frat room!

The problem is, the majority of men suffering from MDD do not want to change and get up before 2-3 PM. Consequently, the MDD spoof was funny the first time I saw, but not so much now.

Consumers International looks like it's based in Australia where direct to consumer (DTC) advertising is not legal. Physician marketing and working with patient organizations, however, is legal and the video above spoofs pharma "marketing" practices disguised as education.

Producing video spoofs of pharmaceutical marketing practices is all the rage these days it seems. Here in the U.S., Consumer Union also produces such videos (see "Consumer Reports Rip Rozerem Ad -- A New One!", for example).

It turns out that there's a connection between CU and CI. According to the FAQs on the CI Web site:

What sort of organisations are Consumers International members and where are they located?
Consumers International's members include a wide range of different independent consumer organisations.

At one end of the scale is the Consumers Union in the US, which was founded almost 70 years ago and has more than 300 staff and 4.5 million individual consumers as its own members. At the other end are semi-voluntary associations providing information and advice and concentrating on education and community development to improve access to food, water and other basic services in some of the world's poorest countries.

Government Affiliates similarly run from major competition and fair trading agencies to recently established government departments in small countries addressing consumer issues for the first time.

About two-thirds of member organisations are in Latin America, Africa, Asia and Central/Eastern Europe and in countries of the former Soviet Union, the other third in Western Europe and North America.
I suppose these spoofs are supposed to be educational, but like the DTC ads they make fun of, I get more entertainment value than educational value from them. It's easy to make fun of pharma marketing practices, especially when your goal is to end these practices. That's where my spoofs making fun of pharma marketing differ from CI's spoofs -- my goal is better, more effective, and more educational pharmaceutical marketing. Just thought I'd point that out.

Thursday, November 15, 2007

Amitiza DTC Ads Won't Win Any Awards, But...

While in a hospital outpatient waiting area last week I was forced to watch "The View" on one of the ubiquitous overhead flat screen TVs that seem to be everywhere these days. Whoopi Goldberg was talking about the "ultimate gift" a mother could give a pregnancy-challenged daughter -- implanting her daughter's embryo in her uterus and delivering her child -- when she was rudely interrupted by the new Amitiza DTC ad.

For those of you who haven't heard, Amitiza is an anti-constipation drug being marketed by Takeda, the folks that bring you Rozerem and Actos. If you believe what you read on Cafe Pharma, Amitiza, which was developed by Sucampo Pharmaceuticals, Inc. -- a drug company I never head of -- is Takeda's #2 selling product (I assume Actos is #1 because Rozerem sure as hell isn't).

I can believe that Amitiza is Takeda's #2 drug. There's been a void in the woman's constipation/Irritable Bowel Syndrome (IBS) market since Novartis withdrew Zelnorm (see "Novartis suspends US marketing and sales of Zelnorm" and other articles here).

The ad could not have been better placed within the show -- interrupting Whoopi speaking to women about difficult pregnancies! Constipation is frequently associated with pregnancy.

Of course, Takeda does not want to limit the market for Amitiza just to pregnant women. Therefore, it is engaged in a bit of "disease mongering" on the Amitiza web site, to whit:

"Chronic Constipation touches the lives of up to 28% of adults in America. Both men and women suffer from it, but the condition is two to three times more common in women."

What exactly "touches upon" means is anybody's guess. Nevertheless, the 28% figure is dutifully repeated in media stories (see, for example, "Amitiza DTC seeks to move constipation sufferers").

In fact, the media go even further and cite these numbers given to reporters by Takeda: "Constipation affects 42 million American adults, and 12 million could be characterized as suffering from chronic idiopathic constipation, the condition for which Amitiza is indicated..."

Let me whip out my trusty Microsoft desktop calculator and do some math.

How many US adults are "touched upon" by "chronic constipation?" There are about 220 million US adults over the age of 20. 28% of that equals about 62 million people. Clearly, that's a much greater number than 42 million adults that are said to suffer from simple "constipation" and much greater than the 12 million sufferers of "chronic idiopathic constipation," which is a form of constipation having an unknown cause. The latter is the "official" FDA approved indication for Amitiza. All the other numbers about simple constipation and "touched upon" seem to have been thrown in to confuse us into thinking that this drug is indicated for a much larger population than the FDA gives it marketing approval for.

Back to the TV ad.

I was struck by how utterly boring the Amitiza TV ad was. This is definitely NOT the kind of ad Abelson Taylor (AT) -- the agency responsible for the Rozerem campaign -- would have done (for an idea of the print ad that AT WOULD have done, see this post).

The ad focuses on women, women's shoes, and women on the move -- by which I mean walking out of the house! The rest was totally unforgettable.

The Amitiza web site is no less boring!

But...

If Amitiza is currently the only Rx out there for chronic constipation (and soon to be approved for IBS as well) and if it is indeed Takeda's #2 drug (in sales as well as indication), then the DTC campaign does not have to be creative (ie, expensive) and "break through the clutter." It merely has to inform the target audience that Amitiza is out there and you can get it!

Given the simplicity of the TV, print, and Web ads, the ROI for the Amitiza campaign must be astronomical!

But...

Meanwhile, Zelnorm has been cleared to return to the market under limited conditions. Too bad. I was looking forward to that day when Takeda would have to rethink its campaign and compete with a new Zelnorm campaign.

I envisioned Takeda turning to AT, its top gun ad agency to break through the clutter.

Here's my concept for the new Amitiza campaign. Forget women's shoes and walking out the house! Bring in the critters! Of course, you can't use beavers or bees or moths. So, I propose "Stippy Stool" pictured on the left.

Thursday, July 19, 2007

The "RLS Gene" Story: Requip Ad Disguised as News on ABC

I couldn't believe my eyes and my ears last night when ABC News devoted significant air time to a story that it claimed "will put an end to criticism of Restless leg Syndrome" or something to that effect.

[I wish I had the video to prove to you that was exactly how this story was introduced. I need a TiVO if I am going to continue in this business!]

In reality, this "news" item was a direct to consumer ad (DTC) for Requip, except without the fair balance! Prominently featured in the opening segment of the ad, er, I mean "news story," were clips from the infamous Requip ads showing the specially-made green chair and a physician mouthing the single word "Requip."

Contrary to ABC News's prediction viz-a-viz shutdown of criticism, there is so much to criticize here that I am at a loss where to begin my renewed criticism! But I will give it a stab.

First, the story is about a scientific study published in the New England Journal of Medicine (NEJM) that claims to have found the gene for Restless Leg Syndrome (see "Restless Legs Scientists Find Sleep-Kicking Gene").

Follow the Money
Let's first follow the money to see if we can catch a "tricky dick" here.

The study, "A Genetic Risk Factor for Periodic Limb Movements in Sleep," was sponsored in part by the Restless Leg Syndrome Foundation, which, as I have pointed out before, is an "astroturf" non-profit established and virtually run by GlaxoSmithkline (GSK), the company that markets Requip for the treatment of RLS.

GSK and Boehringer Ingelheim (BI, maker and marketer of Mirapex, another RLS treatment) are "Gold Level Sponsors" of the Foundation (see "Restless Pharma Marketing"). These companies have an even more incestuous relationship with the RLS Foundation:
The first RLS Foundation Science Award went to Ronald L. Krall, MD, Senior VP of Worldwide Development at GSK! That's a first! Pipe money into a foundation and viola! you (or a VP in your company) gets an award!

Not only that, Dr. Richard Allen, a member of the RLS Foundation's Medical Advisory Board, proudly reveals in the press release that he had the "pleasure" of "collaborating" with the research team selected by Dr. Krall to do studies supposedly supporting the data on the prevalence of RLS in the US and in Europe.
Undoubtedly, the RLS gene study, which originated in Iceland, was one of those "collaborations." (See the RLS Foundation press release.)

OK, we have an industry-created and supported astroturf foundation laundering GSK and BI money to support RLS research in Iceland. It doesn't look good, but the researchers could still be independent and credible, right?

Wrong!

Here's the authors' conflict of interest statement at the bottom of the NEJM article:
"Dr. Rye reports receiving consulting fees from or serving on paid advisory boards for GlaxoSmithKline, Boehringer Ingelheim, Ortho-McNeill, and Sepracor and lecture fees from GlaxoSmithKline and Boehringer Ingelheim; Dr. Bliwise, receiving consulting fees from or serving on paid advisory boards for Takeda, Neurocrine, Sepracor, and Cephalon and lecture fees from Takeda and Boehringer Ingelheim. Dr. K. Stefansson is chief executive officer and Dr. Gulcher is chief scientific officer of deCODE Genetics, and both have equity in the company. The company has a financial interest in the results of this study, including diagnostic products and patents. No other potential conflict of interest relevant to this article was reported."
OK, so we can't trust some of the authors either. But, maybe the science is still OK.

Forgive me for not wishing to delve too deeply into the science, particularly about how strong the connection is between the newly discovered gene and RLS. Let's just say that I don't question the connection between a gene and the condition that the researchers actually studied, which was NOT RLS.

The study was initially done with 306 Icelanders who fit the criteria for RLS and who kicked their legs once they fell asleep -- an action known as periodic limb movements in sleep, or PLMS.

OMG, another acronym for a "real medical condition"!

They also studied 108 Americans in Atlanta.

Quite a convincing N, don't you think? And here I am criticized for my "unscientific" survey with N=145!

The researchers attached a gizmo to the legs of subjects and measured twitches during sleep. The ABC News report showed a graph of someone suffering from PLMS who twitched 60 times an hour during sleep. I am not sure where the cutoff is -- how many twitches per hour is considered "periodic" enough to be PLMS? This is the level of detail I refuse to sink to.

Anyhoo, what does PLMS have to do with RLS?

That's either the Archille's heel of this study or the genesis of a new indication for Requip and a whole new marketing campaign. I envision late-night DTC ads showing scantily-clad babes like that pictured above kicking in their sleep.
NOTE: The photo above is taken from the ABC News Web site version of the story. In the broadcast -- aired during family hours -- a decidedly less attractive woman in jammies and unsexy white socks(!) was used to illustrate what they dubbed "sleep-kicking."
A supposed physician ("docpiner") commenting on the ABC piece had this to say:
"This disease [RLS] has nothing to do sleep kicking. Kicking in sleep is NOT restless leg syndrome. Feeling an uncomfortable sensation in the legs and needing to consciously move the legs to get relief is what this [is] about. This howevere (sic) does not get you your snappy title. You do a disservice to your readers with this type of shoddy reporting."
Indeed, even physicians on GSK's and BI's payroll admit the same:
"It is not a gene per se for RLS, but rather for leg movements seen in individuals and families with RLS," said Dr. John Winkelman, medical director of the Sleep Health Center at Brigham and Women's Hospital. "Whether the same gene is associated with periodic leg movements in [other] contexts, we have no information from this study."

[According to ABC News, Dr. Winkelman "has reported receiving financial support for research, as well as consulting and lecture fees, from Boehringer Ingelheim and GlaxoSmithKline."]
The RLS Foundation, however, has no qualms about playing up the connection between RLS and PLMS:
"PLMS are present in about 90% of people with RLS and are considered a typical expression of RLS."
The Foundation doesn't cite its source for this tidbit of information.

It's interesting that the gene associated with PLMS is found in 65% of all Icelanders and maybe as many Americans.

Whoa boy! Imagine Requip having an new indication for PLMS! Is that a marketer's wet dream or what?!

New Requip Ads Coming Soon?
But new indication or not, I envision new Requip TV ads showing more twitching in sleep than twitching during dinner at a restaurant. GSK already has the YouTube video prototype out there (see "GSK's YouTube Disease Awareness Sponsorship"). Will FDA allow this in branded advertising? Inquiring minds want to know.

Meanwhile, this study sets the stage for the greatest off-label promotion scandal to come. I am sure GSK and BI sales reps and/or Medical Science Liaisons will be out there talking this up to physicians who undoubtedly will be led to equate PLMS with RLS.

Another commenter to the ABC News story shows how easy it will be to confuse RLS with PLM:
I too agree with docpiner it is not sleep kicking. I have had RLS since my last child was born (19 years ago) and it is very annoying. I hated to see evening come. As soon as I would sit or lie down for the evening my legs would start. I finally found Requip about 3 years ago and has provided me with relief so that I could get to sleep. It wears off for me around 6am. My legs get me awake then I have to get up. My legs ache (from the knees down) and also wonder if other RLS sufferers have the same problem.

Monday, June 04, 2007

GSK's YouTube Disease Awareness Sponsorship

Recently, I challenged pharmaceutical marketers to embrace Web 2.0 technologies and even to incorporate consumer YouTube-like videos in their direct-to-consumer (DTC) ads (see, for example, "YouPharma(tm): A Brave New World of Marketing?" and "YouPharma: New Rules for Pharma Marketing and Social Media"; BTW, take our online reader survey and get this reprint FREE!).

It now appears that GlaxoSmithkline (GSK) is the first pharmaceutical company to take me up on my challenge, albeit not in the DTC arena but as an unbranded, sponsored, Restless Leg Syndrome (RLS) disease-awareness YouTube video.



You can click on this image to see the video.

Actually, this video ("My Dad has Restless Leg Syndrome"), which has been viewed more than 73,000 times, was uploaded to YouTube in October, 2006. Therefore, I cannot claim credit for influencing GSK.

The sponsored message at the end of the video states that "My dad is one of a Million people in the UK who suffer from RESTLESS LEG SYNDROME."
Is RLS More Prevalent in the US than in the UK?
GSK, on its U.S. ReQuip Web site, claims "RLS affects approximately 1 in 10 adults living in the United States." That's about 22 million US adults over the age of 20. The UK has about 60 million people, about one-fifth of the US population. Therefore, I would have expected -- based on the US 10% RLS rate cited by GSK -- that there would be approximately 4 Million UK adults with RLS. Yet, GSK estimates only 1 Million. What gives? Is RLS more prevalent in the US than in the UK? Or, are the Brits less susceptible to marketing BS (aka, "disease mongering")? See "Disease Mongering and Pharma Credibility."

I'm not sure how much GSK paid for this YouTube video sponsorship, but 73,000 views is not too shabby. One has to wonder, however, who is viewing this video and what impression it is making.

Luckily, Web 2.0 allows us to get some insight into that question by looking at some of the comments the video has received. Most comments were about how cool it was:
CRAZY!..to long for me

cool... you only need a lot of things and a large house ;)

HAHAHA great video :D must've been fun cleaning up afterwards lol

holy.........snap..........how long did that take you to set up?

the toilet roll was cool. awesome job!
But, there were a few comments mentioned RLS:
I never heard of this so excuse my ignorance. How exactly does it make you suffer to have restless legs? I imagine it is worse for a person in the same bed getting kicked all the time.

First, wow. Second, those are some restless legs. Third, the person that made this must have seen the video Japanese Dominos before they made this.
In my random sampling of comments, I did not find any that looked like they were planted by GSK marketers or their agents. I also did not find any product name mentioned in any of the comments.

At the very end of the video is the "money shot" -- a URL where the viewer can go to find more information about RLS: www.legsinfo.com (ie, http://uk.restlesslegs.com/). The site recommends that you talk to your doctor about treatment. That's about as close as you can get to providing treatment information to consumers in the UK. In the US, on the other hand, unbranded sites can link out to the product site.

How to Move This Into DTC Land
The dominoes video is indeed entertaining, much more so than that specially-designed chair in the ReQuip DTC TV commercials seen in the US. Could the video be adapted to DTC? It would have to be edited so that the product can be mentioned along with the benefits and fair balance side effect information.

Perhaps the dominoes can set off product messages at strategic points, not just at the end as in the current YouTube version.

Some dominoes could represent RLS symptoms being "knocked down."

Etc.

I wonder how the FDA would look at such an ad?

Monday, April 23, 2007

Americans Skeptical Of Pharma Cause Marketing

As Congress considers banning direct-to-consumer (DTC) advertising or at least giving the FDA the power to place a 2- or 3-year moratorium on DTC for new drugs (see "Bill Could Block Some Ads for New Drugs"), the industry is gravitating towards more unbranded disease awareness marketing (aka "cause marketing") programs. Pfizer, for example, is on record saying that it will spend at least as much on such programs in one year as it would on a typical branded DTC campaign.

Pharma disease awareness campaigns can take many forms, one of which is giving "buckets of cash" (aka "educational grants") to patient advocacy groups such as the American Heart Association and other, lesser-known, patient groups. Pharma is also known to create such groups de novo (see "Restless Pharma Marketing"). Disease awareness can also cross the line to "Disease Mongering," in which new medical conditions are created or the incidence of the condition is exaggerated (see "Disease Awareness or Disease Mongering?").

Is it any wonder, therefore, that new a survey by Envision Solutions (see press release here) suggests that many Americans are deeply skeptical of pharmaceutical companies' motives for supporting non-profit patient advocacy groups?

According to the survey, 43% of US adults believe that pharmaceutical companies fund groups like the American Heart Association and the National Kidney Foundation in order to get more people to buy their products or medicines, whereas only 21% believe it is to demonstrate that the companies care about a health issue supported by the group.

Don't Blame the Media!
Envision Solutions also analyzed negative media coverage of pharma support for patient groups and other non-profits and found that such coverage has increased. In particular, Envision suggested unease about pharmaceutical industry support of non-profits may be partly fueled by a recent sharp increase in news stories about “disease mongering” (see, for example, "Disease Mongering: When Is the Line Crossed?").

Disease mongering, however, is not the only pharma cause marketing practice getting negative press these days. For example, the recent Boston Globe article "Drug firms' funding of advocates often escapes government scrutiny" revealed that "In 221 [FDA] advisory committee meetings scrutinized [by Public Citizen, which doesn't receive money form the pharmaceutical industry], 32 of 44 speakers representing patients said they had received funding from a company that would be affected by the FDA's decision...While the FDA scours its advisers' backgrounds for such information [see here], the agency does not require disclosures when patients testify."

You can't blame the media for reporting practices that are clearly suspect. It's time to put the horse before the cart and for the industry to accept some responsibility for the negative press it receives!

Don't Let It Happen Here
In Europe and Australia, where DTC is prohibited, pharma-non-profit cause alliances are practically the only way pharmaceutical companies can reach out to patients. However, abuses "over there" have led to restrictions. Envision Solutions warns that "Americans' deep suspicion of pharmaceutical companies and increasing negative media coverage of their support of non-profits is a recipe for disaster." One such "disaster" would be what happened in the UK and elsewhere: "more aggressive government regulation of drug firm-non-profit partnerships."

There have already been moves in Congress to investigate pharmaceutical support of non-profit groups through educational grants, which are "growing rapidly" according to a New York Times article:
"A Congressional investigation of the money that drug companies give as supposed educational grants has found that the payments are growing rapidly and are sometimes steered by marketing executives to doctors and groups who push unapproved uses of drugs.

"Twenty-three drug makers spent a total of $1.47 billion in 2004 on educational grants, or an average of $64 million per company, according to the Senate Finance Committee. That number was a 20 percent increase from the total in 2003, which was $1.23 billion.' [NYT, "Drug Makers Scrutinized Over Grants", January 11, 2006].
To avoid more regulation in the US, Envision Solutions suggests that "drug firms and non-profits must take steps to increase their transparency and communicate more proactively about their alliances."

Envision Solutions has some recommendations to achieve this goal. Good luck with that!


Listen to this podcast:

Pharma Cause Marketing
A discussion with Fard Johnmar of Envision Solutions focused on his company's recent survey about American opinion of pharma-non-profit cause alliances and the implication for the future of pharma cause marketing....More info here...

  • Airs live, Wednesday, May 2, 2007, 1 PM Eastern US time
    Guest: Fard Johnmar, Envision Solutions, LLC
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