Like most Rx drugs these days, Cymbalta started life approved for one specific indication -- major depressive disorder -- and was later approved for another -- diabetic neuropathic pain -- and now yet another -- generalized anxiety disorder (GAD).
GAD is one of those "real medical conditions" that no one has heard of until a drug has been approved for its treatment.
But it may surprise you to learn that you may suffer bouts of GAD without even knowing it! Here's a patient story taken from the Web site of the National Institute of Mental Health (NIMH):
"I always thought I was just a worrier. I'd feel keyed up and unable to relax. At times it would come and go, and at times it would be constant. It could go on for days. I'd worry about what I was going to fix for a dinner party, or what would be a great present for somebody. I just couldn't let something go."
People with GAD, says NIHM, "are overly concerned about health issues, money, family problems, or difficulties at work."
If you are like me -- one teenager in college constantly overdrafting his expense account and another teenager spending his savings pimping his ride -- you'd be a worrier about money and family problems too! And every day!
But to be truly diagnosed with GAD "a person [must worry] excessively about a variety of everyday problems for at least 6 months," according to NIMH. GAD affects about 6.8 million adult Americans and about twice as many women as men.
Now I just know that Lilly, the company that markets Cymbalta, will make the most of these numbers and portray ordinary worriers like you and me as GAD sufferers.
There some precedent in how Lilly markets Cymbalta that makes me believe it will exaggerate the GAD indication. Lilly's clever "depression hurts" marketing campaign, IMHO, is based on an indication -- ie, pain associated with depression -- for which Cymbalta is NOT approved.
There may be some truth that pain is associated with depression -- Lilly's animated video for physicians says "[depression] is also often associated with a physical component including low energy, changes in sleep and appetite, as well as vague aches and pains of varying degrees of severity..."
Recasting depression's association with "vague aches and pains of varying degrees of severity" into "Depression Hurts" is a stretch in my opinion. Also, I am at a loss as to how "vague aches and pains" fall under the approved labeling for diabetic neuropathic pain. It seems to me that the Depression Hurts campaign smacks of off-label promotion.
Given that, I am worried that Lilly will engage in a bit of GAD disease mongering to sweep as many unsuspecting worriers into doctors' offices demanding Cymbalta. I know I sure would like to stop worrying about my kids every day!
Wednesday, February 28, 2007
Like most Rx drugs these days, Cymbalta started life approved for one specific indication -- major depressive disorder -- and was later approved for another -- diabetic neuropathic pain -- and now yet another -- generalized anxiety disorder (GAD).
Tuesday, February 27, 2007
I attended EXLPharma's "Search Engine Marketing for Pharmaceuticals" conference yesterday and sat in for the two "keynote" presentations made by representatives from Merck and AstraZeneca. In this post I will focus on Ruth Desmond, PhD, Merck's Executive Director, Global e-Marketing.
Dr. Desmond is a bit of an anomaly in several respects.
First, her background is R&D starting as a research chemist and then as a manager of international regulatory affairs. I suppose a lot of people migrate from the research side of pharma to the dark side of "commercialization" (ie, sales and marketing).
It's refreshing to see someone like Dr. Desmond make it in marketing -- she assumed her current position only recently in May 2006. That's the second anomaly. Back before 2001 there were many positions like eMarketing Director within pharmaceutical companies. Then they were all laid off or transitioned into the brand teams. Now it appears that eMarketing Directors are coming back into vogue! At least this jibes with a promise Merck made back in November, 2006 to cut back on television advertising of new drugs in favor of more targeted media such as online internet communities (see "Out with the Bad, In with the Good").
Dr. Desmond admitted that she had a lot to learn about the "e" side of marketing and she illustrated her point using the cartoon shown here on the left. In fact, her presentation really had little to do with technology and focused on basic marketing principles. "Remember the basics of marketing," Desmond said, "and I am sure success will follow."
Maybe this grounding in the basics of marketing and pharmaceutical R&D is the new qualification pharma company eMarketing Directors need to have to be successful. Maybe being too gung-ho on technology for technology's sake was the Achilles' heel of the old guard and the reason for their demise.
Desmond listed four "Ruth Desmondisms" that help her focus on what's important:
- Never neglect the specialists. She illustrated this with her experience in the launch of Proscar, a drug Merck launched years ago to treat benign prostatic hyperplasia (enlarged prostate). According to Desmond, when Merck went straight to GPs with its marketing and bypassed urologists, the latter became anti-Proscar.
- Never believe thine own hype. Dr. Desmond's R&D background may be shining through here. It is interesting to hear this from someone at Merck, which obviously believed its own hype about Vioxx (see "Is Pharmaceutical Marketing BS?").
- Love thy customers. Dr. Desmond cited Apple's practice of giving computers to teachers in NJ and thereby creating loyal advocates who converted kids who will use Macs the rest of their lives. [Sigh! If it were only so!] This got me to thinking how a pharmaceutical company could do something analogous. I guess free drug samples is the most obvious ploy.
- Thou shalt not spray and pray. Dr. Desmond suggests that if Moses went up to the mountain today, he better come back with just 2 or 3 commandments otherwise no one would remember what he said. In marketing, this translates to focusing on 2 or 3 key messages, tops! Sad, but true!
Dr. Desmond did not explain how these principles can be applied to eMarketing or search engine marketing. That was left as an exercise for the audience.
When asked about Merck's eMarketing budget, Dr. Desmond admitted that she couldn't answer that question, not because it was proprietary information, but because she simply did not know. This is a surprising admission for a Director of Global eMarketing whose job is to "get the best for our money" and to promulgate best eMarketing practices in all Merck's markets. She claimed it is really difficult to know what subsidiaries are spending on Internet activities because these dollars are often buried in other categories and not broken out as online expenditures.
I don't know what the power of an "Executive Director" is, but perhaps Dr. Desmond could simply issue the commandment "Tell me how much you are spending on the Internet and where" and it shall be obeyed! I think this should be "Ruth Desmondism" numero 5. Yes, yes, I know, too many messages!
Monday, February 26, 2007
Al Gore's documentary "An Inconvenient Truth" picked up the Oscar last night for best documentary. Like all documentaries, it's a PR piece. But don't expect the film "Innerstate" produced by PR folks at Centocor Inc. to even be nominated for the 80th iteration of the Oscars.
For those of you just awakening from your winter hibernation and who haven't been reading the comments in The Pharma Blogosphere lately, Innerstate is a "new kind of documentary" that tells the "heart-wrenching real stories of three people suffering from immune diseases - rheumatoid arthritis, psoriasis and Crohn's disease..." (see "Taking pharma to the big screen" in Sunday's Philadelphia Inquirer).
Unfortunately, I -- like many other bloggers commenting on this film -- missed the media screening held in NYC on 21 February 2007. So I guess I'll have to wait for the showing in my area on Saturday morning, 28 April 2007. Unless, of course, I receive a special invitation from Centocor's PR people, which I don't expect will happen after they read the following.
I'm not going to be one of those who review this film without having seen it, because you can find that here:
- "Centocor - Remicade - no Oscar for Innerstate" (PharmaGossip) This is not really a review -- it's really a retelling of the Phila Inquirer story
- "The 60-Minute Documentary as DTC Ad" (Pharmalot).
But they should have reached out to bloggers like me and pharma advertising critics like Alexander Sugerman-Brozan, director of the Boston-based Prescription Access Litigation Project. Sugerman-Brozan, you might remember, was a guest on my podcast about disease mongering (listen to the audio archive here).
Sugerman-Brozan measured his criticism carfeully:
"We need to be skeptical of disease-awareness campaigns that come from a company with a vested interest," said Sugerman-Brozan, who has not yet seen the film. "The first out of the gate is not necessarily the problematic one."Maybe if SB was invited to the screening and declined to go, but I suspect, like me, he was not invited. Perhaps he would have been less skeptical and more positive about the film if he had seen it. Hey! It could happen!
So, what's my point other than sour grapes because I wasn't invited to the February 21 screening?
First, if you wish to get fair treatment by bloggers, you need to keep us in the loop. Otherwise, you'll get comments like this:
"Okay, we know DTC ads are under attack for flouting side effects and pushing consumers to ask their docs for meds they don't need. So J&J is being clever. Let's give them that. But let's not pretend a 'documentary' isn't an ad when the producer has such a vested interest. What's next? A Broadway musical featuring children with ADHD who sing and dance their way to a happy ending after taking Concerta?"This was written by journalist blogger Ed Silverman (Pharmalot, op cit) who may or may NOT have seen the film (I suspect not, otherwise he would have mentioned it in his blog post).
Ed's free to have an opinion, informed or otherwise, but wouldn't it be better if he had actually seen the film?
Second, is producing a documentary the right way to do disease education?
Centocor is taking a "hands-on" approach with Innertsate. According to the Inquirer article, "Centocor's director of public relations, Michael Parks, actually served as executive producer and personally sifted through the stories of 40 patients to pick the three for the documentary." He is also overseeing the film's theatrical release.
Other pharmaceutical companies have provided educational grants to independent producers to support disease education documentaries. GSK, for example, provided funding for the PBS show "Fat: What No One is Telling You." GSK, you recall, is marketing the over-the-counter weight loss product Alli (see "Alli Oops! I Just Pooped Myself!").
But even this "hands-off" approach has drawn criticism (see "PBS obesity program under fire"). In this case, however, the criticism was leveled at PBS for accepting the money, not at GSK for providing it!
So, even without seeing Innerstate, I have to say that because Centocor has taken such a hands-on approach in producing it, I cannot trust that the words and stories told by the people in the film were not carefully scripted by the Centocor PR flacks.
In this day and age when user-generated content is ascending and even being used in major brand advertising, it is anachronistic to produce a closely-held film like Innerstate and hope that it will resonate with anyone except marketing/PR insiders who often give awards to one another -- sort of like the Academy of Motion Picture Arts and Sciences.
P.S. For the record, this year I believe all the right people and all the right films won an Oscar!
Thursday, February 22, 2007
Back in October, 2006, I praised the Vytorin ads -- you know, the ones that compare family members to food. I said "I really like these ads. The colors are great and a lot of care went in to the design -- even the backgrounds" and "The Vytorin campaign is very creative, although I'd hate to see what dish I look like" (see "Awards: The Good, The Bad, The Ugly").
But now I'm beginning to grow tired of them and recently I saw the following disturbing iteration of the ad in this week's Newsweek magazine:
On the Vytorin Web site there's another version comparing a black woman with a chocolate souffle!
Why are these "disturbing?" They are reminiscent of a much-criticized comment made by New Orleans mayor Ray Nagin, who once said: "It's time for us to rebuild New Orleans — the one that should be a chocolate New Orleans..." At the time, Nagin was running for re-election and the comment brought much criticism. But it didn't prevent him from being re-elected.
I'm trying to decide if these comparisons have a racial undertone or could be viewed as racist.
Here's a test: What would you think of an image that juxtaposed a vanilla milkshake and a lilly-white Caucasian male?
Just a thought.
Wednesday, February 21, 2007
Merck's lobbying efforts to get states to pass laws requiring that preteen girls be vaccinated against cervical cancer has backfired and Merck's has said it will stop doing it (see "Merck Quits Lobbying for Mandatory Gardasil Vaccination").
It would be interesting to know how much money Merck spent in its efforts. At least one of my blogger colleagues suggested that the money Merck saves from not lobbying could be used to lower the cost of the vaccine, which he claims is the "most expensive vaccine ever" (see "Merck - Gardasil: are we still in Kansas, Toto?").
It's time to engage the left side of our brains and do some math.
First, how much is or was Merck paying for lobbying?
Let's see... Texas Governor Perry is said to have received $6,000. In Kansas, sponsors of a mandatory vaccination bill there have taken in a total of $2,400 (see "Merck's pitiful Gardasil Lobbying Budget -- in Kansas, At Least").
$2,000 here, $6,000 there... pretty soon we are talking... thousands! Not exactly a treasure chest.
Buying a Governor may not be representative of what Merck tried to do in every state -- the model is more like what it did in Kansas. I know, most of us are not in Kansas, so let's say the average Merck spent -- or intended to spend before pulling the plug -- in ALL fifty states was say $5,000 per state or $250,000 in total.
I've always argued that PR is a cheaper form of marketing and this proves it. Look at all the press Gardasil has gotten for that $250,000! You couldn't buy a cheap cable TV commercial spot for that pitiful sum!
Oh, I forgot! The publicity was all negative!
But does it matter? I bet there are many more parents right now talking to their doctors about Gardasil than before all hell broke out over this mandatory vaccination controversy.
But I digress from my little math exercise, which is designed to show how much the price of the vaccine could be reduced IF Merck had decided to give the lobbying money to consumers/voters (by way of rebates) rather than to politicians.
Look, forget the math! It would amount to practically nothing! Spread $250,000 over how many doses/patients? There has got to be a zillion preteen girls in the US! It wouldn't even come to $1 off of the $360 price of the vaccine.
So, there's goes that idea!
But it's interesting how cheap it is to buy a politician. For $6,000 you can get a Governor to stick his neck out and make a controversial decision, bypassing any discussion in his/her state legislature! Wow!
I think it's cheaper to buy a politician than a doctor! I know that a lot of people think doctors are paid off with cheap pens and mugs worth considerably less than $6,000. But these trinkets are for the rank-and-file insignificant docs. The big guns -- ie, key opinion leaders, "consultants", and post-marketing study leaders -- are given an order of magnitude more money than Perry got!
All this leads me to wonder what other issues affecting the pharmaceutical industry are being influenced by lobbying? I know the pharmaceutical industry spends a lot of money on lobbying, but I am too lazy to look up the amount.
It all goes to show how one little mis-step -- involving a minuscule amount of money -- can shine a bad light on the whole industry.
Merck -- slap along side of head -- what were you thinking! PhRMA should have a stupidity fine for any of its members who, due to their stupid actions, further drag the industry's name in the mud.
Tuesday, February 20, 2007
According to a Wall Street Journal News Alert just in, Merck said it will stop lobbying states to pass laws requiring that preteen girls be vaccinated against cervical cancer in the face of a growing backlash among parents, physicians and consumer advocates. Merck's aggressive lobbying campaign was intended to boost sales of its Gardasil vaccine.
"Merck & Co. said it would stop lobbying states to pass laws requiring that preteen girls be vaccinated against cervical cancer in the face of a growing backlash among parents, physicians and consumer advocates.Richard Haupt, Merck's executive director of medical affairs said Merck has "decided at this point not to lobby for school laws any further."
"Merck's aggressive lobbying campaign was intended to boost sales of its Gardasil vaccine, which received Food and Drug Administration approval last year. Gardasil provides protection against two strains of the human papillomavirus that are thought to cause the majority of cervical-cancer cases."
Hurray for Medical Affairs, the "heroes of the pharmaceutical industry" (see "God Bless R&D, but Marketers May Go to Hell!").
We told you so, as you can plainly see from the results of a recent Pharma Marketing poll:
And this is the sentiment of industry insiders, not a bunch of hysterical parents!
Society recognizes that teens don't have the judgement required to evaluate messages related to alcohol, tobacco, etc. So why are some pharmaceutical companies getting away with beaming Insomnia and ED Rx drugs ads to teens on the Web?
James Gardner, a Boston-area marketer who follows online pharmaceutical advertising at his hobby website -- adverlicio.us/pharma, an archive of online pharma ads -- brought the practice to my attention.
"This awakens in me memories of watching the Super Bowl 4-5 years ago and having Bob Dole uncomfortably intrude on a family moment with a discussion of ED," says James. (Actually, the first DTC ads appeared during the Super Bowl game 2 years ago. It was Cialis -- see "Super Bowl DTC Debut: Was It Good for You?" But you get the point.)
James showed me an unbranded FREE OFFER ad for AmbienCR on the site of Seventeen Magazine, but he was particularly concerned about a branded ad for Levitra that he found on the family -- ie, rated E for Everyone -- section of miniclip.com, "an awesomely fun game site." The screen shot is shown below.
This follows a recent Wall Street Journal article that suggests that TV ads for impotence drugs again are crossing the line (see "New Impotence Ads Draw Fire -- Just Like Old Ones").
"In December alone," reports the WSJ, "an ad for impotence drug Viagra aired at around 9 p.m. during 'Prancer,' a G-rated movie about a young girl who nurses one of Santa's reindeers back to health; another spot for rival medicine Levitra appeared during an afternoon showing of the comedy 'Pee-wee's Big Adventure;' and another for Cialis graced an early-evening presentation of the holiday classic 'Miracle on 34th Street.'Blaming the Medium, Not the Message
"Despite a pledge from the pharmaceutical industry to be more careful with prescription-drug advertising, impotence-drug makers are sliding back to tactics that drew widespread criticism from patients, doctors and regulators. A pediatricians' organization is calling for no impotence ads during hours when children are likely to be watching, and a major AIDS group has expressed concern that ads have become too suggestive again, encouraging people who aren't suffering from erectile dysfunction to use the drugs recreationally."
Pfizer and other advertisers claim that ad placement isn't always under their control, especially on cable channels, where unlike network TV, they cannot purchase time on specific shows.
You would think, however, that it would be much easier on the Web to put ads exactly where you want them.
"Levitra has no business on a family gaming site," says Gardner. "Unless miniclip.com is some kind of exception to the rule, every site offers the ability to buy only certain 'channels' (i.e. not the family one), and the ability to predict visitor demographics."
I admit he's got a point.
NOTE: FDA is concerned about unsafe drugs purchased through the Internet (see "FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet"). Maybe they should also worry about drugs being advertised to teenagers on the Internet, especially drugs like ED medications and sleep aids, which have not been tested in children under 18."Advertisers often have an option to alert cable channels in advance when a specific program isn't appropriate for their ads," notes the WSJ. They could do the same thing on Web sites like miniclip.com -- just flag the family section as off limits.
You might defend GSK/Bayer -- the companies responsible for the Levitra ad -- and claim that the agency that does their media buying is responsible. Gardner, however, doesn't buy that defense. He who pays the piper is ultimately responsible.
"Blindly buying media through advertising networks without know exactly where your ads are being placed is not only foolish, it's just plain wrong!" he says.
I second that thought and ask PhRMA again, where are your principles for online DTC advertising?
Dr. Paul Antony, a reserve officer in the U.S. Navy Medical Corps, PhRMA's Chief Medical Officer and Director of its Office of Accountability, may be reading this blog. After all, he did write me to acknowledged my concern over other violations of PhRMA's DTC principles (see "PhRMA Responds to My Rozerem Ad 'Concern'"). If you are reading this Dr. Antony, I invite you to submit a comment in response to my question.
Monday, February 19, 2007
Back on January 29, 2007, I wrote about Takeda's violation of PhRMA's DTC Guiding Principle #10, which prohibits DTC "reminder ads" on TV and in print ads (see "Rozerem Reverts to Reminder TV Ads").
Although Takeda the VERY NEXT DAY claimed that it wasn't a reminder ad at all -- see "Takeda: It Isn't a Reminder Ad --- Wha!!!" -- I begged to differ. On January 31, 2007, I filed a complaint with PhRMA's Office of Accountability and sent copies to Mark Booth, the president of Takeda Pharmaceutical North America and Matt Kuhn, the Takeda spokesperson who claimed no foul (see "Tilting Again at the PhRMA Windmill" for a copy of the letter I sent).
The last time I sent such a compliant to PhRMA -- regarding violation of priciple #10 by another sleep aid brand (Lunesta) -- it took them almost 2 months to send me a response from "Emily," the PhRMA Intern! (see "PhRMA's Response - PRwise, it Stinks!").
This time, I received a response from PhRMA in less than 3 weeks! In it they acknowledge my "specific concern regarding principle #10." View the letter and envelope here.
Unlike last time, the envelope does not have "Office of Accountability" handwritten in crayon over the logo on the front. It's neatly laser-printed on the flap (a cheap alternative to wasting money printing special Office of Accountability envelopes; after all, how many of these letters do you think they send out?).
The letter is actually SIGNED by Paul Antony, MD, MPH, Director, Office of Accountability. In contrast, Emily did not sign her letter nor did she provide her title.
Finally, I am getting the respect I deserve!
Friday, February 16, 2007
Hey you friggin' critics of the pharmaceutical industry! Shut your pie hole! "... drug companies have done a lot more to make my life better than [you] critics have. Maybe someone should point that out more often."
That's what Instapundit writer Glenn Reynolds says in a post cited yesterday by Fard Johnmar over at HealthVox (see "Much Love For Big Pharma In The Blogosphere?").
Aside from the anecdotal nature of this defense, here are five reasons why I hate this "better than the critics" argument made by Instapundit and other "defenders" of the pharmaceutical industry.
Number 1: The Duh! factor. Well, of course, critics -- and I count myself as one, although only 10% of respondents to the First Ever Pharma Blogosphere Survey say I am very critical of the industry whereas 8% say I am very supportive -- don't do much to directly help anyone. I would argue, however, that critics can sometimes make a good thing better. And no one would argue that the pharmaceutical industry could not be improved. After all, only through constant improvement can any public company's share price rise.
They're not ALL angels!
Number 2: Even outlandish Pharma Blogosphere critics like the Insider at PharmaGossip -- rated very critical by 16% of survey respondents -- don't criticize EVERYTHING about the industry. In fact, if anything, we "critics" are very supportive of the R&D side of the business and lament the fact that the corporate/marketing/sales sides have squandered the good will that has been BUILT by R&D over the years. They've done this by paying too much attention to the bottom line than to the core promise of the industry so eloquently enunciated by former Merck CEO and founder George W. Merck many years ago: ""We try never to forget that medicine is for the people. Not for the profits. The profits follow, and if we have remembered that, they have never failed to appear."
Fair Weather Friends?
Number 3: The same people that express love for the industry because it "saved their lives" today, can turn on the industry when they are betrayed. Witness all the people going after Merck because of the Vioxx fiasco. It wasn't even the facts that caused all the hoopla. What brought Merck to its knees -- but not counted out -- was how its sales, marketing, and corporate leadership tried to hide certain facts from the public. Merck recently regained lost good will with the introduction of Gardasil to the Market, which even "critics" like me praise (see "Merck on a Roll!"). I praise it because I can clearly see how this vaccine will save lives (it's a no-brainer).
Yet, for each step forward that R&D takes, greed (ie, marketing, sales, corporate) takes two steps back. I am talking about Merck's lobbying efforts to make vaccination MANDATORY (see "Gardasil: To Be Mandatory or Not To Be Mandatory -- That is the Question"). This is clearly self-serving -- as well as questionable on the grounds of conflict of interest -- because Merck could have waited until competitors entered the market to press for mandates. It also would have been wiser to wait from a patient safety standpoint, something I am sure most of Merck's research and medical staff would agree with.
NOTE: Sixty percent (60%) of respondents to my little poll say that Merck should "absolutely not" press for mandatory vaccination (this "critic" voted that Merck should press for mandatory vaccination but not through aggressive lobbying).
It's Not All About Cancer Drugs
Number 4: Instapundit quotes this comment from a reader to Pfizer: "...we love Pfizer in my house because your exotic anti-arrhythmic drug Tikosyn has changed my wife's life. It's genuinely a miracle drug for her." OK. Pfizer markets some pretty amazing drugs. I haven't seen DTC ads for this particular drug on TV, yet. But Pfizer also wastes a lot of effort and money promoting lifestyle drugs like Viagra and was recently criticized in the Wall Street Journal for promoting Viagra specifically to enhance sexual performance rather than treat a real medical problem (see "New Impotence Ads Draw Fire -- Just Like Old Ones").
Go Ahead, Shoot Yourself in the Foot!
Number 5: The WSJ article illustrates another problem the pharma industry has that deserves criticism: shooting itself in the foot! At a time when Congress is considering legislation to curtail or even prohibit DTC advertising ("Sens. Edward Kennedy (D., Mass.) and Michael Enzi (R., Wyo.) introduced a bill that proposes new restrictions on direct-to-consumer advertising. On Jan. 31, Sens. Christopher Dodd (D., Conn.) and Charles Grassley (R., Iowa) proposed legislation that would require drug makers to submit new ads to the FDA 30 days before they air"), isn't it foolish to "push the envelope" in such a publicly visible way?
Again, greed trumps R&D: sales of ED drugs are not living up to Wall Street expectations -- set by the industry itself -- so ED marketers pull out their big guns -- TV DTC advertising, which is increasing sales all right, but getting the issue on the front pages again! Talking about killing the the golden goose for a quick meal rather than keeping it alive and well it for its valuable eggs!
Give Your Heroes a Voice!
Remember the Istapundit quote that started this rant? Well, here's how a "guy from Pfizer" responded:
"I will pass your thanks along to the guys in the lab. You have no idea how much this kind of message matters to them --and to all of us. We KNOW there's a pony in there somewhere but some days it's not easy to remember that."As if the "guys" in the lab were isolated from public view, locked away in cages like lab rats!
And that's a problem I have always railed against. Time and again, I point out to any industry executive who will listen: give these people a voice (see, for example, the section "Clarence," GSK's R&D Guy, Trumps "Jamie," Pfizer Viagra Guy! in the post "GSK's 'Plain Talk' Flawed"). Here's where the industry should use the power of the blogosphere to improve its image. Want to know how? Call me at 215-504-4164 or email firstname.lastname@example.org
So, God bless the dedicated researchers and scientists of the pharmaceutical industry! They are truly the unsung heroes of the pharmaceutical industry! Too bad they are sequestered in their labs!
What About Marketing?
If God blesses the folks in pharma R&D, the devil may take pharmaceutical marketers -- unless they reform! It's only fair to give the devil his/her due. But take heart marketers, we critics are here to help you escape that awful fate. Want to listen? Or do you want to continue to blame the critics?
Wednesday, February 14, 2007
The Food and Drug Administration (FDA) recently approved Alli, a low-dose form of prescription drug Xenical, as an over-the-counter (OTC) weight loss aid for overweight adults.
No prescription required. Also not required: any mention of unpleasant side effects in DTC ads.
According the FDA, the "most common side effect of the product is a change in bowel habits, which may include loose stools." A look at the Xenical Rx label reveals the details (click the image to enlarge):
Oily spotting, flatus with discharge, fecal urgency, and fatty oily stool ... all occurred in more than 20% of patients taking Xenical in clinical trials according to this label.
Xenical sales, according to reports, has been dismal. "Will Diet Pill alli Succeed Where Prescription Diet Drug Xenical Failed?" That's what one report asks:
"In the eight years that Xenical has been on the market, obese and overweight people around the world have tried the diet drug more than 25 million times. Yet, U.S. sales of Xenical peaked in the year 2000 at about $200 million, making it by any standards not a very successful prescription diet drug.Ya think the Xenical side effects were to blame for the dismal sales compared to Acomplia?
"By comparison, analysts are forecasting that prescription diet drug Acomplia (rimonabant) -- on sale in Europe but still stalled at the Food and Drug Administation -- may ultimately ring up annual sales as high as several billion dollars." (See "Will Diet Pill alli Succeed Where Prescription Diet Drug Xenical Failed?")
Now that GSK is executing its Rx to OTC strategy with Xenical, will sales improve?
You bet they will!
And the reason they will is that finally GSK marketers can talk about the benefits without giving equal time (fair balance) to those unpleasant side effects. On the MyAlli Web site, side effect information is buried in press releases and watered down somewhat as in "Consuming a meal with too much fat, while taking alli, can result in bowel changes such as having an urgent need to use the bathroom." You can find that buried in the 9th paragraph of the GSK press release.
If you click on "How Does It Work" and then find the "important safety information" link on that page and scan down below the page fold, you will find a few carefully wordsmithed phrases designed to tone down the shitty imagery somewhat:
- gas with oily spotting
- loose stools
- more frequent stools that may be hard to control
I find it ironic that GSK/FDA point that these side effects can be minimized by eating a low-fat diet. Of course, if we all did that we wouldn't need an Alli in the first place.
Of course, you could always pick up a box of Depends at the next counter over when you purchase your Alli at the drug store.
Tuesday, February 13, 2007
Today at 1 PM I interview an expert in "Customer Manages Relationship" marketing in my weekly Pharma Talk Podcast. You can listen in live! via your browser by going to the Pharma Marketing Talk Channel Page at 1 PM Eastern, today! The audio streams right from that page without you having to do anything but visit the page at the right time.
SORRY! DUE TO TECHNICAL DIFFICULTIES, THIS PODCAST DID NOT STREAM OUT AND YOU WON'T BE ABLE TO LISTEN TO AN ARCHIVE! I plan, however, to cover this topic in a future Pharma Marketing News article.
What is Customer Manages Rleationship Marketing?
The new marketing strategy of CMR - Customer Manages Relationship - is one way that pharma marketers can create a new beginning with their patients and customers.
How? By letting the patient in. Let them add their voices to your communications. How do you do this? First you must embrace the reality that people-to-people communications are more powerful than any DTC ad or unbranded education Web site. And that by letting the patient have the venue to create a community or state an opinion facilitated by your company is the best way to channel the power of peer-to-peer communications.
Customer Manages Relationship is taking off fast; it was inevitable once marketers saw the power of community and CMR sites (Myspace, Youtube, even Dove.com and Hellmans.com.) that they would figure out a way to embrace this as a tool to harness the power of peer-to-peer recommendations. And this can also be done offline, too, through grassroots and other community efforts.
Now it is Pharma's turn to not "turtle" behind regulatory over-caution, and instead find a way to incorporate the power this new strategy brings and the positive impact it could have on both your company, your brand and to helping consumers manage the relationship.
Interview of Alfred O'Neil
In today's podcast, I will be interviewing Alfred O'Neil, Senior Vice President, Group Director of Ryan TrueHealth, the healthcare division of Ryan iDirect, an integrated Relationship Marketing agency that has been around for more than a decade.
Some questions I intend to ask include:
- Who is the customer as far as pharmaceutical cpmpanies are concerned? Some think it's the physician. Others say the patient. Which are we talking about?
- What's the difference between CMR and CRM (Customer Relationship Management)? Is CMR just new wine in an old bottle? Hasn't CRM been a disaster at pharma companies?
- Some of CMR's concepts like peer-to-peer relationships, customer voice, people-to-people communications, sound like social network marketing. Are we talking about blogs, podcasts, etc?
- Explain how you see a CMR marketing strategy helping pharma companies regain consumer trust. You mention advocacy. Hasn't this been part of pharma's marketing strategy for a long time?
- Air Date & Time: Tuesday, February 13, 2007, 1 PM Eastern US time
- Duration: Approx. 30-45 minutes
- Go to the Pharma Marketing Talk Channel Page for listening live and downloading audio archive instructions
P.S. You might be interested in this collection of reprints from Pharma Marketing News:
Direct, Targeted, Permission-based Marketing Builds Relationships, Increases ROI and Improves Patient Compliance
Table of Contents
Order the PDF for Delivery Via Email
Monday, February 12, 2007
The only two pharmaceutical-related TV ads aired during the Super Bowl were flops, according to a Research Brief from The Center for Media Research, which reported on a USA Today survey ("USA TODAY's Super Bowl Ad Meter").
The two 60-second (ie, VERY EXPENSIVE) ads were King Pharmaceuticals' disease awareness heart risk ad ("Guy in heart suit attacked by risks") and Boehringer Ingelheim's Flomax branded DTC ad ("Prostate drug lets men bike, kayak").
You can see all the Super Bowl ads here.
The King Pharma ad scored 5.23 (vs. an 8.56 for the most popular ad, which was Budweiser's 30-second "Crabs worship Bud ice chest" ad. The Flomax ad was one of the 5 least popular with a 4.22 rating.
Popular No, Web Traffic Increase Yes!
With regard to market share of web visits on Super Bowl Sunday versus Feb 3, 2007, King Pharma's site (www.beatyourrisk.com) got the biggest change in market share of all advertisers: 1727%! No surprise there -- it could be that the site's traffic increased from say 10 visitors on February 3, 2007 to about 172 on Super Bowl Sunday. I'd say that was worth the $3-5 million or so King paid for the spot, wouldn't you.
BTW, as pointed out by Insider at PharmaGossip, the biggest risk for heart disease was not mentioned in the ad or included in the calculator at the site. Can you guess what it was?
Decrease in Semen!
Yep, that was a possible side effect mentioned in the Flomax ad along with several others. Is it any wonder this ad was nearly at the bottom of the rating pile! I am NOT making a case for limiting side effect information in DTC ads. But if you are going to show an ad on one of the manliest sports events broadcast in the US, you got to have your head screwed on backwards if your ad mentions "decrease in semen flow!" That kind of ad should only appear when there's less testosterone flowing in the bodies of the target audience.
File this under What were they thinking!
A recent article in The Scientist suggested that the "answer to stagnating R&D can be found in the creativity of the movie industry" (see "Why Pharma Must Go Hollywood").
Interestingly, I wrote about the analogy between pharmaceutical marketing and sales and how Hollywood back in August, 2005 (see "Movies and Drugs: Same Blockbuster Mentality"). My thoughts were based on an article in the New Yorker critical of the Hollywood blockbuster model. My premise was that if it isn't working very well for Hollywood, it won't work very well for the pharmaceutical industry.
It turns out that maybe the way Bollywood -- as the movie industry centered in Mumbai (aka Bombay) India is referred to -- does business may be a better model for the pharmaceutical industry to follow, even R&D-wise.
The cost of tickets in the movie industry is analogous to the cost of drugs in the pharmaceutical industry.
Movie tickets for Bollywood films in India are the cheapest in the world. According to an article in the Wikipedi encyclopedia, "Bollywood sold 3.6 billion tickets and had total revenues (theatre tickets, DVDs, television etc.) of US$1.3 billion, whereas Hollywood films sold 2.6 billion tickets and generated total revenues (again from all formats) of US$51 billion."
NOTE: Bollywood makes more money in after-sales of music CDs from films than from ticket sales. Perhaps the pharma industry should pay more attention to its CD/DVD sales. Big pharma companies -- the ones who invented the drug in the first place -- should continue to sell the patented drug as a generic or over-the-counter (OTC) product after the patent runs out.Lower Development Costs
How come so cheap? Bollywood budgets are usually modest by Hollywood standards.
"The average cost of producing, marketing and distributing a Hollywood film is more than US$60 million though a Star Wars or Harry Potter costs around $100 million and only one out of ten succeeds. At the same time Shekhar Kapur’s ‘Paani’ which is tipped to be the costliest film ever to be made in Bollywood will cost $20 million and the average cost of a big movie is around $ 5 Million." ("Bollywood vs Hollywood - The Complete Breakdown")
If the pharmaceutical industry could bring the cost of developing a new drug down one-third (from an industry-estimated $800 - $1,200 million per drug), then it too may be able to lower its ticket price and get more needy (eg, under-insured) Americans into theatres (doctors' offices).
Friday, February 09, 2007
We have a 13+year old chow/australian shep. mix that is holding up pretty well except for some arthritis which is being controlled with Glucosamine and Aspirin. The problem is that she sometimes is extremely restless and acts anxious, suddenly getting up and hurrying off, only to come back in and wander around as if searching for something. She will go to a rug or dog bed and start digging at it, pulling it towards her. Sometimes moving it all around the room, leaving herself out of breath. Sometimes she just digs at a spot in the carpet or a pile of papers on the floor. It sometimes goes on for several days with her walking around the house all night,approaching the bed panting. Nothing seems to help her relax. She seems to have a normal appetite, but she is losing weight slowly from all the activity. Anyone out there have any experience with similar symptoms? Thanks. CG Dear CG --
It sounds like your pooch may be suffering from Over Anxious Doggie Syndrome (OADS). But there's good news! America's pharmaceutical industry has developed an innovative new drug for OADS! Actually, it's an old drug approved for a new indication.
According to a Bloomberg Health and Science report, "A variation of Eli Lilly & Co.'s depression pill Prozac can now be used to help dogs cope with the anxiety of being separated from their owners. The product, to be sold under the name Reconcile, is designed to help quell panic attacks and bad behavior that separation anxiety can cause. The chewable drug should be used in conjunction with a behavior modification plan, the U.S. Food and Drug Administration said today in a notice posted on the agency's Web site."
While your mutt may not fit the exact indication for which Lilly's new drug has been approved, we all know that Vets can prescribe it as they see fit.
According to the prescribing information "Dogs on the drug should also receive behavior counseling, such as rewards for good behavior and training to be content alone."
Forget about such life style changes! Who's got time for that! Certainly not your 13 yo mutt! She's practically a goner anyway. So don't worry about side effects either!
Lassie, the official spokesdog for Reconcile, often goes into a funk when she can't convey the message to humans that Timmy's down the well again. "Arf, arf, arf, arf arrrrrf!" says Lassie, which translated means "Over Anxious Doggie Syndrome is a real medical condition that affects over 50% of dogs in the US."
I have written about the Rozerem advertising debacle repeatedly, pointing out how inane it is and worse, how it has been ineffectual in helping the brand gain market share.
This point of view is not radical. It's shared by many experts and journalists who write on the subject, although they have to report that the emperor has a wonderful suit of clothes on.
Take, for example, the short article "For Rozerem DTC Campaign, it's steady as she goes" in the February, 2007 issue of MM&M, an industry publication I greatly admire.
"CONSUMERS WILL see more of Honest Abe this year, despite lackluster sales of Rozerem," says MM&M. The article goes on to quote Paul Broidy, director of neuroscience marketing for Takeda Pharmaceutical NA: "If there's a theme,it's steady growth and keeping the strategy that we have."
IMHO, this "circle the wagons", "stay the course" approach may be politically correct and is probably the only course of action available to someone who was responsible for the strategy in the first place (I'm talking about Paul Broidy, not someone else).
Maybe it's time for a change in leaders?
And trade publications and journalists continue to drink their Kool Aid! MM&M isn't the only one I'm thinking of. See "Rozerem Ads Innovatively Ineffectual" for another example of jingo-pharma journalism.
Each time such a Rozerem story appears a new nail is added to the coffin if only people were to look at the numbers instead of the rhetoric. In the MM&M article you can find total retail sales numbers and DTC media spend numbers for the major insomnia brands. Using these numbers, I came up with the ROI plot shown on the left. [If you need to know how I calculated this from the published numbers, submit a comment to this blog.]
Aside from the Rozerem DTC campaign being in negative territory -- something I noticed several months ago -- it has not even been able to get Rozerem sales above that of Sonata for which "no [DTC] spend was detected! For the July to November, 2006 period Rozerem retails sales were $37.15 million whereas the Sonata sales during the same period was $38.91 million!
I'm not yet ready to say that all DTC is ineffectual -- after all, both the Lunesta and Ambien CR campaigns seem to be able to muster positive ROIs. But don't you think your strategy needs reworking if your campaign is in negative territory?
Let's finally admit that the emperor has no clothes!
P.S. New shows that Rozerem's DTC ROI is even deeper in negative territory than I estimated (see "Rozerem Ad Spending Exceeds Sales!").
Thursday, February 08, 2007
I started smoking when I was 9 years old, picking half-smoked butts off the street. I quit one day at the age of 23. I simply threw the half pack of cigarettes into the trash and never had another one since.
Now that's cold turkey!
It turns out that cold turkey, which is definitely one of those "lifestyle changes" that PhRMA recommends DTC advertisers talk about in their ads, may be a better way to quit smoking in the long run than nicotine patches, gum, and anti-smoking drugs marketed by the pharmaceutical industry. So says, anyway, an article in today's Wall Street Journal (see "Behind Antismoking Policy, Influence of Drug Industry").
In the WSJ article you'll find this interesting chart based on "population studies -- which review results of people who already quit or tried to, rather than prospectively randomizing subjects into groups..." These studies suggest that "cold-turkey quitting can compete with medication in real-world situations." (You old folks like me: Click on the chart for a larger view.)
Of course, GSK takes exception to this government study:
"Kenneth Strahs, GlaxoSmithKline's vice president of smoking-control research and development, notes that his company's products won approval from regulators at the Food and Drug Administration who demand randomized clinical trials. 'The FDA does not conclude either safety or efficacy based on retrospective population studies,' says Dr. Strahs."I'm sure the FDA will back you up on that Dr. Strahs.
Life Style Change Issue
But I what I want to ask is why did GSK , which markets Nicorette gum and nicotine-laced Commit lozenges for quiting smoking, create the "Don't Go Cold Turkey" campaign focused on doctors? [This makes the cartoon shown on this page irrelevant if not humorous.]
It seems to me that coming out AGAINST a life-style change is against the spirit of PhRMA's DTC Principle 9 (Information on Other Treatment Options) which encourages drug marketers to "include information about the availability of other options such as diet and lifestyle changes where appropriate for the advertised condition."
[Yes, I know the DTC principles don't apply here. But now I'm interested to see what GSK says in its Nicorette TV commercials about life style changes.]
If you go to GSK's quit.com site (sponsored by Nicorette), you'll find some anti-cold turkey statements in the FAQs:
Q: I've tried quitting before, but have always failed. Is my willpower just not strong enough?I didn't bother to find out where GSK came up with the 5% success rate for cold turkey as opposed to the 16% rate suggested by the National Cancer Institute, which is part of the The National Institutes of Health (NIH).
A: Don't be so hard on yourself! The success rate for people who try to quit cold turkey is a dismal 5%. The difference now is that we have a variety of stop-smoking Quit Aids that can increase your chances of success by lessening those awful withdrawal symptoms: irritability, lethargy, trouble concentrating and hunger.
BTW, NIH got a very high rating in a recent Harris Interactive poll of US opinion of 13 federal agencies ("CDC, FAA, NIH, FDA, FBI and USDA Get the Highest Ratings of Thirteen Federal Government Agencies").
Not that one thing has anything to do with another thing -- NOT!.
Tuesday, February 06, 2007
Won't anyone defend Merck's campaign to mandate the vaccination of school girls with Gardasil?
Even fellow blogger and industry supporter Rich Myer over at World of DTC Marketing claims this issue "is a prime example of what's wrong with pharma and adds to the public perception that pharma is only in it for the money" (see "A prime example of whats wrong with Pharma (Gardasil)").
The brouhaha over Gardasil was heightened when Texas Republican governor Richard Perry signed an executive order requiring school girls to be vaccinated with Gardasil (see "Texas Gov. Orders Anti-Cancer Vaccine" and "Texas vaccine mandate draws GOP ire").
You would think that vaccination against a form of cancer would be a no-brainer. Maybe I am too close to this. We lost a very dear friend to ovarian cancer. She was only thirty-something, had two small daughters, and was literally a saint (that's how she was eulogized by the priest at her funeral).
I am on record saying how courageous I thought Merck was in bucking the religious right who claim that vaccination against HPV will promote promiscuity (see "Merck On a Roll").
Aside from the promiscuity red herring, there are a few other issues with mandatory vaccination that critics raise, including:
- It's too expensive (see World of DTC Marketing for a discussion of this issue).
- It's not covered by all insurance plans (neither was Viagra in the beginning, but you didn't hear about male promiscuity).
- The risks are unknown.
- Merck is engaging in "Astroturf" grass-roots support efforts through an organization called Women in Government, mostly composed of state legislators and pharma companies.
- Collusion of the governor with Merck lobbyists
Risk and Lobbying
Ever since Vioxx was removed form the market, drug risk has been a hot topic and lightening rod for criticizing the drug industry. But let's not forget that the main problem in the Vioxx case was the fact that Merck had a campaign to hide the risks it knew about and "dodge" the issue.
We now hear the mantra that "all drugs have risks" and this is certainly true. Patients need to know the risks as well as the benefits and be able to make an informed decision. The problem is when their trust is shattered by industry cover-ups. Hopefully, this won't happen with Gardasil.
If you are my age, you remember being lined up for polio shots in school. There was no choice -- I am not even sure parents could have opted out of the vaccinations on religious grounds as they can in the case of Gardasil vaccination in Texas. And there was never any discussion of risk then.
Unfortunately, I don't think anyone has enough knowledge of what the risks are with Gardasil and the polio vaccination experience may serve as a warning.
So, maybe it's not a good idea on the grounds of unknown risk to force mandatory vaccinations at this time. Merck, therefore, should back off from lobbying states to make it mandatory.
That's my opinion. What's yours?
Sunday, February 04, 2007
The Pharma Blogosphere blog is currently hosting its first ever survey of reader and blogger opinions of blogs in the pharma blogosphere. I want your opinion too. So please take about 3-4 minutes answering this survey.
Everyone completing the survey may order a free copy (pdf file) of one of the following Pharma Marketing News Special Supplements:
Good deal, eh?
I am also interested in bloggers' opinions about their fellow bloggers! So, fellow bloggers, don't be shy! Take the survey and enter your blog name where indicated.
- Which pharma-focused blogs do you read and how often?
- What are the benefits to you of reading these blogs?
- Rate the blogs you have read according to readability, credibility, and usefulness.
- How supportive or critical of the pharmaceutical industry are the blogs that your have read?
That is, I do not reveal how any identifiable person voted unless I am given permission to do so. For example, you might be interested in my personal opinions or perhaps how the Insider at PharmaGossip voted. Of course, you will get my opinion in spades as time goes on. Just take a look at my review of Drug Wonks (see "Drug Wonks Are PR Wonks"). But, if you want Insider's or another blogger's opinion, I will have to ask their permission first.
Regardless, aggregated results will be reported here when the survey is closed. In that summary, I will segment out the opinions based on the category of respondent. F0r example, I can compare how pharma people voted versus everyone else. I can also see how pharmabloggers in aggregate voted compared to everyone else.
Even at this early stage, the results look very interesting. Hope you will help and take the survey now!