Pharma Marketing Blog

Will Viagra be Approved for Antidepressant-Related Sexual Dysfunction in Women?

2008-07-22T14:45:00.002-05:00

Women with sexual dysfunction caused by the use of antidepressants experienced a reduction in adverse sexual effects with use of sildenafil, commonly known as the erectile dysfunction medication Viagra, according to a study in the July 23/30 issue of JAMA (JAMA. 2008;300[4]:395-404).

I could not verify that this study was funded by Pfizer in time for this post -- the principal author, H. George Nurnberg, M.D., of the University of New Mexico School of Medicine's Department of Psychiatry, declined to be interviewed. Dr. Nurnberg, however, has published other papers on related research for which he received funding from Pfizer (see, for example, "Sildenafil Citrate for the Management of Antidepressant-Associated Erectile Dysfunction"). The financial disclosure included in that published study states:

Dr. Nurnberg has served as a consultant to Pfizer, Eli Lilly,
SmithKline, Bristol-Myers, and Glaxo; has received grant/
research support from Pfizer, Eli Lilly, SmithKline, Bristol-
Myers, Abbott, Lipha, Johnson & Johnson, Parke-Davis, and
Wyeth; and has served on the speakers bureau for Pfizer, Eli
Lilly, SmithKline, Bristol-Myers, Abbott, Glaxo, and Wyeth.
Dr. Hensley has received grant/research support from Forest,
Pfizer, and Hoffman-LaRoche and has received honoraria from
and has served on the speakers or advisory boards for Forest,
Pfizer, and Wyeth.

So, it's pretty safe to assume that Pfizer also supported his study regarding anti-depressant sexual dysfunction in women.

Studies like this could be used to buttress Pfizer's expansion of its Viagra franchise by seeking FDA approval for new indications for Viagra. Currently, Viagra is approved only for marketing as a treatment for men with erectile dysfunction (ED). There has been some signs that Pfizer is seeking other indications for Viagra, including premature ejaculation (see "PEED: A New Viagra Franchise?").

The holy grail, however, would be an indication for enhancing women's sexual function. Initial trials of Viagra in women proved highly disappointing, however. "True, the drug enhanced engorgement of vaginal tissue, just as it had of the penis," reports the NY Times, "but that extra bit of pelvic swelling did nothing to amplify women’s desire for or enjoyment of sex" (see "The Search for the Female Equivalent of Viagra")

The next best thing would be to treat sexual dysfunction in women who take antidepressants! And there are a LOT of women in this category! "Do the math," says Jim Edwards in his blog post "Worst Side Effect Ever: The 'Pleasureless Orgasm.'"

"SSRI antidepressants — such as Paxil, Lexapro, Zoloft, Luvox and Prozac — have rates of 'decreased libido, delayed orgasm, anorgasmia, erectile dysfunction, and difficulties with arousal, of between 36 and 70%,' according to a new study," says Edwards.

Edwards continues: "According to Scientific American, close to 10% of Americans are on antidepressants. Let’s make it easy and say that’s 30 million of 300 million yanks. Of those, possibly 23 million are walking around in a state of sexual frustration. And they have partners — so that’s somewhere in the neighborhood of a possible 46 million of us who are inexplicably tetchy and bad tempered on most days."

Of that 46 million, I'd hazard a guess that 70% or 32 million are women. This is potentially a tremendously huge new market for Viagra -- much larger than the puny premature ejaculation market!

I suspect it may be pretty easy for Pfizer to get the FDA to approve Viagra for treatment of antidepressant-related sexual dysfunction in women. As the authors of the study note "By treating this bothersome treatment-associated adverse effect in patients who have been effectively treated for depression, but need to continue on their medication to avoid relapse or recurrence, patients can remain antidepressant-adherent, reduce the current high rates of premature medication discontinuation, and improve depression disease management outcomes."

"Improving outcomes" is currently the magic key that can open many doors at FDA.

Once Viagra is approved for anti-depressant sexual dysfunction in women, one door that definitely will open is the door to off-label use of Viagra by all women as a party drug no matter if it works or not for that purpose.

Update: Bloomberg.com reports that Pfizer sponsored the study through a grant but "has no plans to seek regulatory approval for Viagra as a treatment for female sexual dysfunction," according to spokeswoman Sally Beatty in a July 21 e-mail. The company is looking into other treatment approaches for women, she said (see "Viagra May Help Women Restore Orgasms Lost to Antidepressants").

Hmmm...we'll see. Maybe there will be a groundswell of demand from women on anti-depressants for Pfizer to seek approval. I suggest that we keep an eye out for off-label prescriptions for Viagra written by doctors for women on anti-depressants. Unfortunately for less affluent women, medical insurance and Medicare won't pay for unapproved uses of drugs. I also predict an enlarged black market for Viagra and more Viagra spam e-mail messages being sent to women!

Pharma DTC Ads Portray Women as Weak and Battered Victims

2008-07-21T06:11:00.008-05:00

I have received many comments about posts that poke fun at direct-to-consumer (DTC) ads that portray women as weak, battered, and victims of esoteric syndromes that actually afflict very few women.

My posts should have conveyed my belief that most DTC ads depict women in a negative way, whereas men are depicted positively. Unfortunately, I failed to convey that point because of mistakes I made.

A case in point is a post I made about PGAD -- Persistent Genital Arousal Disorder (see "PGAD. EGAD! Another Syndrome/Disorder, Whatever!").

The first mistake I made was the title of that post, which was snarky and implied that PGAD was a phony medical condition. Of course, my blog post titles are meant to capture people's attention and get them to read the post, which contain pearls of wisdom about pharmaceutical marketing.

Another mistake I made is not challenging other bloggers for putting my comments in the wrong context. Kevin, M.D.'s blog, for example, wrote this:

Persistent genital arousal disorder

Physicians aren't sure how to treat this:

. . . a 33-year-old housewife and mother in South Carolina, became so desperate she voluntarily had herself committed — twice — to psychiatric institutions. "One psychiatrist said I must be sexually repressed and needed to experiment more," she says. "He suggested I try lesbianism."

Update: Apparently, others have thought the same thing.

(See Kevin's post here.)

Kevin linked to my PGAD post as an example of "others" who have thought the "same thing," by which readers might infer I think the same thing as that "psychariatrist." This, of course, is not the case if you bother to read my entire post.

Apparently, some women who suffer from PGAD HAVE read my post. Here's a comment from one of them:

This is post is very upsetting. So you think all women complaining about this disorder are making it up? you think there is no such disorder? I have this and it is very disturbing and painful. Imagine living your life 24 hours a day feeling like you are in the middle of having sex! It is not funny or desirable. People with PGAD, are not thinking about sex- don't want to have sex- it has nothing to do with sexual desire!!!- yet your genitals are constantly aroused. You can't concentrate on anything, you sit around praying and thinking of ways to get the feeling to stop but nothing works. I am hopeless because I can't find any help, crying at my computer because there is nothing to help this disorder and then I come across this asshole. It is painful and I feel like I am going insain, and having sex doesn't help it so if Paxil does than give me some please.

OK, like Dennis Leary, I've been called an asshole many times. Goes with the territory.

My post about PGAD imagined what a fictitious DTC ad about a PGAD drug (eg, Paxil, if approved by FDA for PGAD) would look like. It ended more on an anti-male note than an anti-female note: the woman happily cycles off into the sunset and exclaims: "Thanks to Paxil, PGAD is not a problem any longer. Riding my bike also helps. And I got rid of my loser husband!" And she didn't go riding off with another woman!

But that's not my point!

Here's My Point
First of all, DTC ads for Rx treatments of medical conditions like PGAD, RLS, fibromyalgia, various forms of depression, etc., imply that many more women suffer from these conditions than is supported by the evidence. That generates an impression in my mind of women in general rather than a very small subset of women.

Secondly, the impression of women I am getting from most DTC ads is that most women suffer from depression -- I see very few men in these ads -- have mysterious, hard-to-define syndromes -- and are really distressed about "going" -- compare the DETROL ads depicting women who fret that everyone knows they have a bladder problem to the active, happy-go-lucky men suffering from enlarged prostates in the FLOMAX ads. DTC ads also show women as being battered (see, for example, "Battered Woman Imagery in Pfizer's New Fibromyalgia Ad") and generally victims who really really need help from a pill in order to be happy!

Is this the image that women want to relate to?

Yes, I know there are women out there who DO suffer from these conditions. I'm just objecting to the way that women are objectified in DTC ads! Apparently, others have thought the same thing.

In contrast to most women in DTC ads, most of the men I see in Rx drug ads are strong and vibrantly alive -- even erectile dysfunction sufferers are young, happy, and virile men with great looking women partners who are HOT for them! I almost envy them!

Objectification of Women
Case in point: the Evista ads (see here) and the PGAD news item, in which I see an image of a woman appearing in a major news source (MSNBC) objectified as a cartoon vagina. BTW, I did not create this image; I stole it directly from MSNBC. OK, this is not a DTC ad per se, but it illustrates how women are portrayed not just by pharma marketers, but in the media in general.

The fact is most women in DTC ads are protrayed as victims and overly dependent upon products created by a male-dominated industry.

There is one exception that may prove the rule: the ad for Amitiza. The woman in this ad has a medical problem, but it's not detracting from her attitude and there is a positive feeling as she goes about her apparentky successful life.

So, what's my point?

DTC advertisers: Stop making it appear that American woman in general are beset by debilitating, strange, difficult to diagnose syndromes!

And most importantly, stop depicting women as victims!

That's my opinion and I'm sticking to it!

Can a Moratorium-delayed DTC Ad Refer to a Drug as "New"?

2008-07-17T09:22:00.011-05:00

Last month, WSJ Health Blog reported that "Drugmakers [Merck, Pfzier, J&J, to name a few] called before Congress to explain their direct-to-consumer [DTC] ads have agreed to wait six months before advertising newly approved drugs to the general public."

But I wonder if marketers in these companies have has asked themselves this question:

Given DDMAC’s policy that a new drug can only be new for six months after marketing launch, does that mean that brands who observe a 6-month or longer DTCA moratorium cannot claim "new" in their consumer ads?

That was a question recently posed by a client to my long-time colleague and Pharma Marketing Roundtable member, Mario Cavallini, Manager of Competitive Intelligence at Rosetta Marketing, who answered:

Interesting question; I don’t know whether anybody’s put those two together before.

The FDA guideline that a prescription med can only be "new" for six months comes (I believe, but could be mistaken on this) not from firm legislation but from "case law" pattern of rulings by DDMAC [Division of Drug Marketing, Advertising and Communications; the FDA division responsible for overseeing drug promotions].

In any event, the “six months for ‘new’ status” rule predates the PhRMA DTC Guiding Principles, which introduced the moratorium. Strictly speaking, the Guiding Principles only call for “an appropriate amount of time to educate health professionals about a new medicine or new therapeutic indication before commencing the first DTC advertising campaign” (by which, the Guiding Principles specifically means broadcast media and print advertising, but not Web sites and online media). How long and how broad the moratorium should be is left to the discretion of the individual company and brand. Six months is typical, but some have a one-year policy, some shorter.

PhRMA offers no guidance on whether the “new” clock starts at FDA approval, brand launch, or campaign launch. However, according to the FAQ page at DDMAC, the clock starts at campaign launch:
DDMAC generally considers that "New" is an accurate description of the marketing phase for six months from the time a product is initially marketed. This should be distinguished from the time the product is cleared by FDA for marketing.
So, on the one hand, it seems clear that the 6-month “new” clock starts at the end of the moratorium. But remember that the PhRMA guidelines only cover so-called mass media. DDMAC does not make such a distinction; if a brand puts up a brand Web site and runs banners within days of FDA approval, and then six months later starts running TV ads with “new” in the creative, I really can’t say whether that will be a problem or not.

Given that the point to the PhRMA moratorium is to allow marketing to HCPs before the messaging to consumers kicks in, my GUESS is that DDMAC would start the "marketing clock" at product launch, not campaign launch. That is, as soon as HCP marketing begins, that product is marketed and the 6-month clock starts.

Will this compel companies that observe a 6-month moratorium to NOT launch a Web site for the drug until the end of the moratorium? I don't think so because the FDA and the industry have always considered brand web sites as labeling, not DTC advertising.

What if they put up a banner ad on consumer sites to draw consumers to the brand site? Does that start the "marketing clock?"

Inquiring minds want to know!

How Risky are Rx Drugs?

2008-07-17T06:52:00.008-05:00

There's been a lot of brouhaha over the perception that the FDA is currently "risk adverse" and too quick to require "black box" warnings on Rx drug labeling (see these articles in Pharma Marketing Network's "Industry News" Forum). The FDA uses the black box as a blunt instrument to ensure that drug marketers adequate communicate major risks to physicians and consumers. Physicians may read the drug labeling -- though I'm not sure about this because I cannot recall any studies that show that physicians DO read the labeling -- but it is pretty well established that consumers never see the labeling (aka package insert or PI) let alone read it.

The issue of communicating drug risk to consumers was covered in the April, 2008, issue of Pharma Marketing News (see "DTC Risk Communication"). This article summarizes the discussion I moderated during a panel session at a recent conference. The experts on the panel included: Scott M. Lassman, Partner, FDA Group, WilmerHale LLP; Hugo Stephenson, President, iGUARD.org; and Harry Sweeney, formerly Chairman, Dorland-Sweeney. I've interviewed Dr. Stephenson about iGuard in a Pharma Marketing Talk Podcast (listen to it here: "An Innovative System for Communicating Drug Risks to Patients") and Harry is a long-time friend and member of my Roundtable of advisors (see here). I met Scott Lassman for the first time at this conference. Prior to his position at WilmerHale LLP, Lassman served as Senior Assistant General Counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA).

Side Bar: Scott recalled my name because while working at PhRMA he heard of my PhRMA Intern blog posts and he told me that the posts drove "Emily," the hapless REAL PhRMA staffer who famously responded to my inquiries with an amateurishly-written, extremely late reply (see "PhRMA's Response - PRwise, it Stinks!"), to eventually leave PhRMA!

Harry's Drug Risk-o-Meter Parlor Game
Harry Sweeney suggested that before you can communicate risk and determine who should communicate risk to whom (FDA to drug company, FDA to consumers, drug company to consumers, drug company to physicians-then to patients, FDA to physicians-then to patients, etc.), it is necessary to define what we mean by risk.

"We ought to clarify that risk is a lot more than odds and probability," said Sweeney. "You have to have a hazard. You have to be exposed to the hazard. Then there’s proportion -- the magnitude of the risk, which is not discussed in the pharmaceutical world. We are given tiny numbers upon which to make important major communications policy decisions."

Sweeney pointed out the need for a baseline of what consumers understand about drug risk before we can move the needle where it ought to be. To illustrate what he meant, he engaged the audience in a "parlor game:"

Imagine a scale in front of you with a zero at one end and a ten at the other. Zero is extremely risky (not safe) and ten is extremely safe. Put your finger somewhere on the scale in answer to the question: "How safe are prescription drugs?"

"Imagine doing this in a roomful of people more representative of the general public," said Sweeney.

Well, since the article was published, I have been inviting people visiting the article summary page to participate in Harry' Drug Risk Parlor Game (a one-question online survey) and here is a plot of the results so far:

There are not enough responses to make this even close to scientific, but I note a peak on the "risky" side. I'd like to have many more responses to get a better sense of how risky readers thank drugs in general are, so you are invited to play Harry’s Drug Risk Parlor Game online here.

Thank you!

Is This OK Under PhRMA's New Code?

2008-07-16T15:11:00.006-05:00

I'm getting some pretty amusing responses to the following question asked in my Survey regarding PhRMA's New Code on Interactions with Physicians:

The code document has a Q&A section that lists several scenarios that are allowed or disallowed by the code. Here's an example: "A district sales manager at Company C invites 30 physicians to a corporate suite at a professional baseball game for a 45-minute scientific and educational presentation followed by a buffet and the three-hour game. Does this conform to the Code?" Just for fun, can you can think up a scenario that may need to be reviewed by PhRMA to determine if it IS or IS NOT permissible under the new guidelines?

The response that inspired the image shown here was:

A district sales manager at Company C invites 30 physicians to a strip club for a 45-minute scientific and educational presentation. The rep speaks from the speaker booth and the presentation is a power point which is projected on a screen on the stage behind the stripper pole, while food, drinks, and lap dances are served to the physicians at their seats in front of the stage. (please de-identify me, thanks!)

You are de-identified sir!

Do you have any other scenarios that I can submit to PhRMA for their feedback? Tell me by taking the survey here.

Results of this survey will be used to inform an ongoing Pharma Marketing Roundtable discussion, which you may join. This discussion and survey results will be summarized in an issue of Pharma Marketing News.

Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally

Thanks!

FDA Intern Gets Her Bonus!

2008-07-14T13:51:00.006-05:00

According to a CBS News story -- "FDA Execs Reap Lavish Bonuses" -- 28 senior FDA executives took in a combined $1 million in bonuses last year.

"They've done such a miserable job these last two years, I think they should leave! Not get bonuses of $40,000 [to] $50,000!" Rep. Bart Stupak, D-Mich., said. "Good grief."

"What we are talking about here is the need to have highly experienced, highly capable technical experts that, without which, the country would suffer," said FDA Commissioner Andrew von Eschenbach.

"These should be referred to not as retention bonuses but blackmail bonuses," said Tom Schatz, president of Citizens Against Government Waste.

All this has not gone unnoticed by Emily, the intern at FDA, as we document in this installment of FDA INTERN!

"Candid Camera" Research Into Physician-Patient Interactions

2008-07-14T09:39:00.006-05:00

The folks at MBS/Vox, part of CommonHealth, "a research-based consultancy specializing in the physician-patient dialogue," are at it again with their "candid camera" doctor's office research.

You may remember CommonHealth's claim that drug advertisers don't know how DTC works. They based that conclusion on video recordings of physician-patient communications during office visits. CommonHealth claimed that very few patients asked for a brand name that they saw in a recent DTC ad. Therefore, DTC does not work by causing patients to ask for brand name drugs. Ergo, DTC works, but we don't know why. I totally destroyed the validity of the conclusions of that research in a previous post to this blog (see "Advertisers Don't Know How DTC Works. Say wha?").

I received an email today from my friends over at PharmaVoice inviting me to download a free "Thought Leader" article entitled "Everyone Wins When Clients Can Help Physicians and Patients Speak the Same Language".

The article described some new research by CommonHealth and it specifically described the "Candid Camera" approach used: "Video cameras catch every sound and movement, so words and visual cues can be analyzed simultaneously. Targeting practices based on clients’ needs focus the research on key conversations that are meaningful to specific brands within an evolving marketplace."

First, I assume that the research is done with the full knowledge and approval by both physicians and patients and that it was compliant with relevant HIPAA privacy regulations and state laws.

Second, I assume the physicians involved get paid for allowing CommonHealth to install the "candid cameras" and interview them and their patients afterward.

Although the research is billed as a way that pharmaceutical companies can help improve physician-patient communications by helping physicians and patients "speak the same language," it obviously may be a more useful to CommonHealth's pharma clients, who can "demonstrate value to physicians beyond just the benefit of the brand, potentially creating an unexpected, yet mutually beneficial relationship." Ie, sell more drugs.

So, is this research or a sales tactic?

The author categorizes this research as belonging ton the field of "sociolinguistics." I've previously suggested this kind of research is bogus (see here). Therefore, I would call it "bogolinguistic research." As such, does it comply with PhRMA's new guidelines and "reinforce [the pharmaceutical industry's] intention that [their] interactions with healthcare professionals are professional exchanges designed to benefit patients and to enhance the practice of medicine"? You tell me!

Is This Permitted Under New Code of Interactions with Health Professionals?

2008-07-14T09:09:00.004-05:00

I'm getting some pretty good responses to my Online Survey regarding PhRMA's New Code of Interactions with Health Professionals. See and take the survey here.

Results of this survey will be used to inform an ongoing Pharma Marketing Roundtable discussion, which you may join. This discussion and survey results will be summarized in an issue of Pharma Marketing News.

Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally

The survey asks some serious questions (see preview here). One question, however, was thrown in just for fun. It asked: Can you can think up a scenario that may need to be reviewed by PhRMA to determine if it IS or IS NOT permissible under the new guidelines?

Here's one response to that challenge:

Doc and drug rep have season tickets next to each other for their local football team. Doc buys the first round, rep buys second round. Is this a violation of the code?

What do you think? Allowed or not allowed?

One thing's for certain. Many of these kinds of "gifts" will never be disclosed by the parties involved and unless PhRMA has agents posing as doctors, we'll never know how much gift-giving is going on "under the table" and assigned to budget line items such as "physician education."

Pharma Marketers Sometimes View Patients Merely as Symptoms to be Treated

2008-07-11T07:05:00.008-05:00

"...a feature common to most drug ads: they leave you confused about the information," says Kate Pickert, a Time Magazine reporter and author of the article "Do Consumers Understand Drug Ads?"

I'd say that that most drug ads leave me confused about how pharmaceutical companies view consumers and patients.

Take for example the cute ENABLEX TV ads that depict people as colorful urine-filled balloons. Is THAT how Novartis and P&G, marketers of ENABLEX, a treatment for overactive bladder, view people?

Here are images I captured from the ad (you can view the entire ad on http://www.enablex.com/):

This certainly does not leave me confused about what happens when you have overactive bladder! It takes me back to my youth in summer throwing water balloons at passersby.

It also reminds me of a cartoon I did a long time ago for a health information booklet. It depicts how specialist physicians sometimes view patients' medical problems only through their narrow specialist perspective.

The criticism is that the whole patient is not looked at. In the case of overactive bladder (OAB), for example, that symptom might be caused by a more serious problem that ENABLEX does not address. Here's what the Mayo Clinic says may cause OAB symptoms:

"In many cases doctors can't exactly identify overactive bladder causes. Neurological disorders, such as Parkinson's disease or strokes, are often associated with overactive bladder.

"Several factors may cause or contribute to symptoms similar to those of overactive bladder and your doctor will try to rule out these during an evaluation, because these require other specialized treatments. These include:
Urinary tract infection
Inflammation of tissues near the urinary tract
Abnormalities in the bladder, such as tumors
Factors that obstruct bladder outflow (enlarged prostate, constipation, bladder stones, or previous operations to treat other forms of incontinence)
Diabetes, which can cause excess urine production
Excess consumption of caffeine or alcohol
Medications that cause a rapid increase in urine production

That last one is interesting: you may be taking one drug to counteract the symptoms of another!

What's Your Opinion of PhRMA's New Code?

2008-07-10T10:41:00.005-05:00

Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors adopted measures to enhance the PhRMA Code on Interactions with Healthcare Professionals.

Among its changes, the revised Code (learn more here):

Prohibits distribution of non-educational items (such as pens, mugs and other "reminder" objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, "may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues."

Regarding CME, the new code specifically states that a pharmaceutical company should separate its CME grant-making functions from its sales and marketing departments.

Regarding use of non-patient identified prescriber data, the new code specifies that companies should voluntarily respect and abide by the wishes of any healthcare professional who asks that his or her prescriber data not be made available to company sales representatives.

Regarding disclosure requirements for healthcare providers who are members of committees that set formularies or develop clinical practice guidelines and who also serve as speakers or consultants for a pharmaceutical company, the new code specifies that pharmaceutical companies should require these healthcare providers to disclose to the committee the existence and nature of his or her relationship with the company. This disclosure requirement should extend for at least two years beyond the termination of any speaker or consultant arrangement.

Regarding compliance, the new code states that companies that publicly announce their commitment to abide by the Code and who complete an annual certification that they have policies and procedures in place to foster compliance with the Code will be identified by PhRMA on a public web site. The certification must be signed by the company’s Chief Executive Officer and Chief Compliance Officer.

Please take 2 minutes to answer this survey, which asks your opinion about the code in general and about the above specific provisions of the code.

Results of this survey will be used to inform an ongoing Pharma Marketing Roundtable discussion, which you may join. This discussion and survey results will be summarized in an issue of Pharma Marketing News.

Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally.

After taking the survey, you will be able to review a de-identified summary of results.

Pharma Vendor and Ad Agency Diversity: All Talk, No Action?

2008-07-09T08:38:00.006-05:00

Craig DeLarge, Associate Director, eMarketing & Relationship Marketing at Novo Nordisk Inc., was a featured speaker at the 4th Annual Pharma Networking Dinner Reception that I hosted at the Princeton, NJ Marriott on June 4, 2008.

DeLarge spoke on the Life Science Profiles of Color Project and blog (see here), the goals of which are to encourage and offer guidance to young people seeking to achieve success in the life sciences industry and to highlight the contribution of people of color in the life sciences.

DeLarge's profile is the first one published on the LSPOC blog. He ended his LSPOC profile with these words:

"The benefits of the industry’s diversity initiatives, racially and otherwise," says DeLarge, "have been greater reflection of our customers in our organizations with the corresponding benefits of greater innovation and openness, customer empathy and broader more relevant perspectives. While there is always more to be done, in 20 years, I have seen pharma manufacturers come along way. That said, the service and vendor sides of the industry is seemingly lagging behind its clients."

The issue of diversity—or lack thereof—in the NYC advertising agency world was highlighted recently in the AdAge blog post “Agencies Have Funny Way of Showing 'Commitment' to Diversity” by Ken Wheaton who criticized the lack of ad agency presence at a recent New York City Commission on Human Rights public meeting.

“… it's not fun to sit there and put faces and names to the stories you hear in the industry,” wrote Wheaton. “It's not fun to see grown men and women wrestling with a mix of pride and frustration, to sense that they're just this close to throwing their hands up in defeat and that you, an agency executive, are partly responsible. It's uncomfortable to hear a 20-something black man who has an agency job call this ‘the most discouraging business to be in.’ It isn't easy to try to distill the cases of racial discrimination from those of talent discrimination, to parse the inside stories and personal grudges that haunt a corner of the industry that most executives probably don't even know exist.”

“There are many reasons why the agency world looks more like a gated community than a global one,” wrote Wheaton. “There is a lack of awareness in certain minority enclaves; portfolio schools are expensive. The starting pay stinks for qualified candidates who can get better jobs with marketers. Not all of these are excuses.

“But they start to sound that way when the executives in question don't have the decency to give the problem its due, don't have the balls to show up in person and look these people in the eye.

“Not showing up also allows charges to go unanswered. Rafee Kamaal, a TV producer, likened the industry to insects when calling for more attention to the matter. ‘Roaches scatter when you shine the light on them.’ Others said that a system of discrimination is ‘embedded in the industry.’ Euro RSCG was named-checked no fewer than three times in last night's meeting -- and it wasn't for enlightened hiring practices.”

Comments to Wheaton’s tirade include the following:

“The problem isn't NYC tho. As I and others can attest, it's not just a New York thing. If the will and the stomach for seeing the mess out in the open were there, you could hold hearings in every city from Orange County, NJ to Orange County, CA and you'd find exactly the same level of collusion and bias in effect.” -- –Eric J. Henderson, New York, NY

“I've seen what happens when you speak out in this industry. I've seen it up close and personal. It's not pretty what can be done to you. Personally, I've had enough. It's a broken system and there are too many people who enjoy maintaining the status quo.” –hadji williams, chicago, IL

UPDATE: Of the 16 ad agencies forced to sign diversity-hiring agreements with the New York Commission on Human Rights in 2006, only two sent representatives to the latest progress meeting this week. Ad Age Features and Blogs Editor Ken Wheaton was a member of the tiny audience at that gathering. He wonders aloud how companies that are such experts in creating and nurturing corporate images can so neglect their own when it comes to racial diversity. See video here.

The issue of racism and diversity in the pharmaceutical industry will be the topic of an article in the upcoming issue of Pharma Marketing News to be published on July 16, 2008. Subscribe now and get this issue sent to you FREE via e-mail.

A Novel Approach to Communicating with Physicians

2008-07-08T07:11:00.006-05:00

That's the title of a Pharma Marketing News article I wrote some time ago about "a patent-pending technology" developed by a company called MagicMedia Communications. It offers a novel way for pharmaceutical sales representatives to "talk" to a doctor…even when face-to-face discussion is not possible!

I didn't give the secret away in the summary of the article, but I can now tell you that it was a "talking greeting card." You've probably seen Hallmark Cards TV ads that show someone recording a personalized audio message on a card they will send to a friend or relative. Cute!

That was the idea behind what MagicMedia was offering to pharmaceutical companies. The idea was to leave behind a card with a sales message when the physician was too busy to see the rep. The original idea was to allow the sales rep to compose a unique message for each physician. I saw problems, however, with this idea and advised the company that pharmaceutical companies must carefully control what sales reps say to physicians because of regulations prohibiting off-label communications among other worries. The product was redesigned so that the messages were pre-recorded by the sales rep and pre-approved by the legal/regulatory people. The message could not be recorded over in the field, or so I was told.

Direct Mail PharmaUnabomber Wannabee
Anyway, the reason I bring all this up is because of a story I read in the San Diego Union Tribune about a talking greeting card sent to a medical office by a pharmaceutical company. It was news-worthy only because a medical receptionist heard "ticking" coming from a mailbox in which the card was delivered. Here's the complete story:

Ticking card greets bomb squad

The ticking noise that brought a bomb squad to a Carmel Valley medical building Monday turned out to be a small battery in a greeting card.

The card, from a pharmaceutical company promoting its products, said "Your time is up" on the cover, San Diego fire spokesman Maurice Luque said.

A receptionist at Children's Medical Group office in the three-story building on El Camino Real heard ticking coming from a mailbox in the hallway about 4 p.m. She called 911 and security officers evacuated the building.

The Metro Arson Strike Team bomb squad and a U.S. Postal Service inspector were called in, Luque said. The greeting card was removed and opened, and the battery inside was found to have been damaged.

Luque said the card was addressed to a doctor who no longer worked there. The Postal Inspector was going to contact the pharmaceutical company about their promotional efforts.

Ed Silverman over at Pharmalot called this "Just Another Dumb Promotion." Dumb indeed! The first rule of direct mail campaigns is make sure your list is current and accurate! Sending such expensive promo items to doctors that aren't there is really dumb. OK, the message "You're Time is UP" on the envelope and the "ticking" were just as dumb. One wonders how such a campaign made it through legal/regulatory review!

I also wonder which is the pharmaceutical company, aka PharmaUnabomber wannabee, NOT mentioned in the article? Amylin Pharmaceuticals is headquartered in San Diego. Inquiring minds want to know!

AAP Guidelines May Help Extend the Patent Life of Lipitor

2008-07-07T12:25:00.008-05:00

Pfizer is searching for a way to maintain the LIPITOR franchise and the American Academy of Pediatrics (AAP) may have just supplied the solution: A new indication for the treatment of high cholesterol in children over 8 years old!

In new guidelines, AAP states: "For children who are more than eight years old and who have high LDL concentrations, cholesterol-reducing medications should be considered" (see AAP press release).

Of course, AAP does not specifically recommend LIPITOR or any other anti-cholesterol drug, but I bet this is giving Pfizer some ideas such as that illustrated here (or perhaps Pfizer gave the AAP the idea to develop new guidelines in the first place?).

Note that few drugs are officially indicated for use in children. Lipitor's label, for example, states "Pharmacokinetic data in the pediatric population are not available."

It is theoretically possible for Pfizer to get extended patent protection for LIPITOR if it ran some clinical trials in children under 12 and if the FDA approved the new indication based on those studies. Hey, it could happen! It's been done before for other drugs.

Sorry Trix rabbit, "Lipitor is for kids, not rabbits -- no yet anyway!"

FDA Intern vs. Inebriated Advisory Committee Antagonist

2008-07-02T13:19:00.014-05:00

Yes, it's FDA Intern! Strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even FDA commish Andy von Eschenbach!

FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding bullet, jump through Congressional Subcommittee hoops of fire and ire, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great regulatory agency, fights a never ending battle for fast-track drug approvals, pharmaceutical company user fees, and the FDA way!

For the "Fans of Emily, PhRMA Intern" who have missed her adventures, I am pleased to announce that she has moved over to take on the job of FDA Intern, which is a switch from the usual career development path from public service to private sector. But, Emily is just an Intern and is wise to learn the ways of FDA. Besides, PhRMA gave her the boot and FDA lately has been desperate to fill vacancies.

No sooner was FDA Intern ensconced in her diminutive, windowless office than she came upon an article published in The RPM Report about new security measures being imposed at public advisory committee meetings.

"If we anticipate that there may be an increased need for security at a particular meeting because it is a particularly controversial topic," said an FDA spokesperson, "we may have additional security procedures."

As reported in The RPM Report, those procedures include:

Creating a physical barrier by roping off the committee from the public. The intent, [FDA spokesperson] said, is "to put some separation between those who might become agitated in the audience and committee members." (For taxpayers, it carries another benefit—preventing the public from sneaking pastries off the committee’s breakfast tray.)
Increasing the presence of security guards in the committee room—both in uniform and street clothes.
Reading a statement at the start of the meeting about "good rules of behavior."

Immediately thinking that her services were needed, mild-manner Emily Jameson quickly assumes her alto ego -- FDA Intern!

Minutes later, traveling faster than an FDA warning letter to a drug company CEO, FDA Intern arrives at the advisory meeting in progress at an adjacent building. Bursting through the door, she immediately confronts Joe public asking embarrassing questions.

Yes, FDA Intern foils another attempt at disrupting the lawful activities of the FDA in carrying out its duty to efficiently approve drugs for marketing.

We will assuredly report in this forum the further adventures of FDA Intern as she tackles even more evil and insidious enemies of FDA who are also after the doughnuts and refuse to stand behind the ropes!

Meanwhile, if you hear of any of FDA Intern's exploits that should be reported on here, please contact this reporter at johnmack@virsci.com.

If Doctors, Like Nascar Drivers, Wore Their Sponsors' Logos

2008-07-01T13:23:00.004-05:00

I found this cartoon in the current issue of New Yorker Magazine:

Come to think of it, this might be a good way for doctors to supplement their incomes AND it would be transparent to patients from which companies their doctors received gifts.

New alli Plan to Gain Market Share: Eliminate the Competition!

2008-07-01T12:45:00.004-05:00

Yesterday, I said that I opted out of my alli challenge and won't be trying it (see "I Opt-Out of My alli Challenge!"). I felt it required just too much effort and expense.

I neglected to mention that the diet aisle at my local CVS was crowded with other weight loss products -- mostly dietary supplements, which are loosely regulated: they are considered foods and do not have to go through safety and efficacy testing to gain FDA approval. Supplements can make "structure and function" claims -- such as "calcium builds strong bones" -- but they cannot claim to treat disease.

GSK, the marketer of the weight-loss OTC drug alli, according to this story in the NJ Star-Ledger, has filed a petition with the FDA "to require supplement companies making weight-loss claims to conduct clinical studies to prove their products work, then win government approval before they can be marketed."

Obviously, GSK has failed to win as much market share as it would like and instead of gaining share based on the debatable merits of alli has opted to try and eliminate the competition.

As reported by the NJ Star-Ledger, "Glaxo reported $315 million in sales for Alli from its launch last July through March of this year. Information Resources, a Chicago-based market research firm, said the top 19 over-the-counter weight control brands other than Alli had $227 million in sales, excluding Wal-Mart stores, during the 52 weeks ending May 18."

In other words, alli already has about 58% of the OTC weight control market, but would like more and wants it by default rather than by outcomes!

I noted in yesterday's post that alli had a prime, top-of-the-shelf position in the diet supplement aisle of my CVS store. It stood alone in terms of its advanced, expensive-looking point-of-sale display; no other weight loss product bothered to do anything like it. I doubt if any other OTC weight loss product on that shelf spent 1% as much on advertising as did alli to gain its 58% market share. alli marketing, in fact, may be in negative territory considering all the TV ads, web sites, blogs, PR, fancy packaging, and in-store advertising that it is doing.

So it's not that alli sales are weak. Sales just have not been enough to cover the marketing nut!

40over40: Lilly's DTC ED Awareness Campaign in the UK

2008-07-01T06:46:00.006-05:00

For those of you who believe there's no such thing as direct to consumer (DTC) "advertising" outside the US, let me offer this: "Lilly launches television campaign for ED awareness."

Although this campaign is technically "direct to consumer" it does not qualify as "advertising" under European law because it is unbranded, which means that no drug trade name is mentioned and there is no direct inducement to buy a product. Such unbranded DTC disease awareness advertising is also common in the US (see, for example, Pfizer's recent battered woman fibromyalgia disease awareness ad campaign described here).

The Lilly campaign, dubbed '40over40', is said to be "groundbreaking" being the "first time a UK-targeted campaign of this kind has appeared on British television."

"The campaign aims to dispel the common belief that erectile dysfunction affects only elderly men. It has been dubbed '40over40' due to new statistics that show erectile dysfunction (ED) actually affects 40% of men over the age of 40."

An integral part of the campaign is the 40over40.com Website, which claims "This site is designed to help you enjoy your love life again." This site fits in with Lilly's plan to "encourage sex between couples" (see "Look Out for Sexier Cialis Ads -- Maybe Including Beaver!").

This whole notion that ED "affects" 40% of men over 40 is something I take issue with and have noted before as ED drug DTC ads in the US portrayed younger and younger men as sufferers of ED (see here). As the chart on the left shows, I saw this coming over 3 years ago.

According to 40over40: "Erectile Dysfunction (ED) is a common condition, 40% of men over 40 suffer from some degree of erection problem. If you are one of the 40% of men over 40 who also has experienced this problem you're certainly not alone and you've arrived at the right site for reassurance and advice."

The operative phrase is "some degree," which is another one of those "subjective" phrases that can mean almost anything. What Lilly wants you to think, however, is that 40% of men over 40 suffer from ED, period! Not from rare or occasional problems getting an erection -- not that there's anything wrong with that!

Now here comes the interesting part.

A section of the 40over40.com site is about "ED treatment options," which includes a table listing oral treatments, penile injections (ouch!), and vacuum pumps (hmmmm...). But due to EU laws banning DTC advertising, the site cannot mention oral treatments by name and must refer to them as "product 1," "product 2," and "product 3."

Visitors are urged to talk to their doctors about treatment options -- doc, I would like "product 1" please. Huh? I suppose Lilly sales reps can prep doctors so that they know that "product 1" = Cialis when UK guys come in and ask for it.

Soon, however, pharmaceutical companies in Europe may be able to distribute drug information such as Patient Information Leaflets (PILs) to consumers and 400ver40.com may be updated to allow UK guys to download a PIL about Cialis.

But remember that "news" article I linked to above entitled "Lilly launches television campaign for ED awareness"? That's the PR Rosetta stone that allows UK consumers to decipher that "product 1" is really Cialis: the article tells us that Lilly markets Cialis and is also responsible for 40over40.com.

Who says there is no DTC advertising in Europe?

I Opt-Out of My alli Challenge!

2008-06-30T12:32:00.006-05:00

Sorry, but I just cannot bring myself to try alli as I challenged myself to do a few days ago (see "Take alli - I dare you!").

I went to my local CVS and spotted the diet section and alli was there in a very prominent, top-shelf location with lots of pamphlets, neat flip open panels that displayed information about alli ("what is alli?", "how does it work?", "what's the plan?" -- just flip up the panel and find out!) and even a window-shade gizmo that could be pulled down to reveal 6 questions or conditions I should agree to before trying alli.

Plan? Commitment?

What? Am I getting married to this product?

Somehow it made me feel right off the bat that if the pill didn't work, it was my fault for not being committed enough and not following the plan! Sounds like marriage to me!

[Maybe the commitment and plan stuff appeals more to women than to men?]

Then there was the cost of $49.95 for the "starter kit" which was a bulky white box that contained booklets, a portable pill case, and a bottle of 60 pills -- enough for 20 days. I did a quick calculation and learned that I would have to take three pills each day! Like Sally Field, I have enough things to do and don't want to worry about taking all those pills! Just give me one pill I can take every month and let me sit or stand for 30 minutes -- done!

So I realized that the price would be an issue -- nearly $75 per month! -- and compliance also -- remembering to take a pill with each meal (or before or after -- I didn't stick around to find out which) and I also had to remember to bring along the pill case when I eat out.

Of course, I already knew about the oily discharge "treatment effect" and I was willing to accept that challenge. The box suggested, however, that I start a low fat diet BEFORE I started taking alli. Jeez! If I was that committed, I wouldn't need the damn pill!

Then I read the back of the starter kit where it said that alli may interfere with the absorption of vitamins and I should take my multi-vitamin at bedtime. OK, that would require another change in my daily regimen!

Add to all that the comments I received by e-mail from fans who were wishing me luck but expressed concern that I would fail.

What I learned is that alli has a few problems other than its famous "treatment effect" that may be holding back sales.

Marketing Mix of Leading Pharma Advertisers

2008-06-30T06:00:00.014-05:00

Thirteen (13) pharmaceutical companies made it into AdAge's 2008 list of 100 National Advertisers. They are:

GlaxoSmithKline
Johnson & Johnson
Pfizer
Schering-Plough Corp.
Wyeth
Bayer
Bristol-Myers Squibb Co.
Eli Lilly & Co.
Merck & Co.
AstraZeneca
Novartis
Boehringer Ingelheim
Sanofi-Aventis

The list is based on "measured media" spending across 19 media and includes estimates of "unmeasured media," which includes direct marketing, product placement, and most notably, paid Internet search, which some analysts estimate is about 40% of the total ad spend of companies in general.

New to the list this year is Boehringer Ingelheim, which markets Mirapex for Restless Leg Syndrome in competition with GSK's Requip.

The total spend for these 13 pharma companies in 2007 was $6,998,700,000 measured vs. and estimated $6,834,600,000 unmeasured. That represents 13.1% of the total spending in 2007 of the entire group. NOTE: Not all of this represents direct-to-consumer (DTC) advertising. Magazines, for example, include B-2-B publications (ie, medical journals focused on physicians).

I plotted the media mix for pharma advertisers vs. non-pharma companies in the list and came up with this (click on the image for a larger view):

Based on these data, the top spending pharma companies have a media mix distinctly different from the top non-pharma companies. Pharma devotes a greater slice of its advertising pie to TV and magazines than do non-pharma companies. In fact, 92% of pharma's budget is devoted to these two categories of media! That leaves scant dollars for other media.

It makes sense that pharma would not spend as large a portion of its ad budget on newspapers, radio, and outdoor venues. These media focus on local markets rather than mass markets and pharma has little need to tailor their messages to local markets (although some drug categories may benefit from more exposure in communities with disproportionate medical problems, such as diabetes in African-American neighborhoods).

Why Pharma Lags in Internet Advertising
But it is surprising that pharmaceutical companies -- at least the 13 in this group of top spenders -- devotes only 3.1% of their ad budgets on the Internet whereas non-pharmaceutical companies devote 7.3% of their budgets to the Internet.

Why is this?

I believe that most pharmaceutical marketers have a mass-market mentality and do not view the Internet as a mass market medium. Every defense I've heard from these marketers for why they are not spending much on the Internet includes the phrase "lack of reach" in comparison to TV and magazines. True enough.

Also, the Internet is not nearly as motivating as TV in getting consumers to visit their doctors and ask for a specific brand of drug, which is the goal of all direct-to-consumer pharmaceutical advertising.

Not until the Internet, in the minds of pharmaceutical marketers, becomes more like TV, will the needle move on pharma Internet-based DTC advertising.

Rich Media Can Change Pharma's Mind About the Internet
But guess what! The Internet is becoming much more like TV because of Rich Media, which includes streaming audio video (eg, podcasts), animations and other programs that engage viewers like TV does, but also allows them to interact with the advertisement in ways that are not possible with TV.

More and more, I have seen pharmaceutical Web sites that embed videos of their latest TV ads. Some have even solicited consumer-generated videos for submission to YouTube.

I've been experimenting myself with rich media -- see "Blogs are Done! What’s Next for Pharma Marketing?". My most recent endeavor in this area is what I call a Vendor Video Showcase that I introduced at my June 4, 2008 Networking Dinner Reception.

For some time I have maintained an online directory of pharmaceutical vendors, solution providers, and consultants over at the Pharma Marketing Network portal (see www.vendors.pharma-mkting.com).

Up until now it was your typical static, Yellow pages type listing with text, maybe a graphical logo and links to the advertiser's Web site. The text included a short 150-250 word "pitch" for why pharmaceutical companies should hire the company in the listing.

Very standard stuff. Not terribly engaging and it doesn't give you a feel for the people who run the company. The Vendor Video Showcase is a new and exciting promotional option for the directory that helps overcome this limitation. It features an embedded video "sales pitch" included in the listing in which a company representative -- the CEO is best -- makes a 1-minute presentation about the company and what it has to offer. To see this in action, please visit the Consultants, Management/Strategy page of the directory and listen to Jan Heybroek, President of The Arcas Group. Jan's video pitch was recorded live at the networking dinner.

Aside from the video embedded in the listing, what's neat about this is that the video is also posted to my YouTube Channel where people -- eg, current and former clients of The Arcas Group -- can post comments (eg, testimonials) and rate the video. Just like pharma companies, however, advertisers may consider these "social media" aspects a double-edged sword. There is always the option to turn these functions off or to moderate comments before publishing them. The other advantage of housing the videos on YouTube is that they can be found by a Google search, which adds to the utility.

Pharma Marketing Network’s Vendor Video Showcase is the first online pharmaceutical marketing directory to offer rich media options. To learn more about this service, download the Vendor Video Showcase Fact Sheet (pdf file).

Battered Woman Imagery in Pfizer's New Fibromyalgia Ad

2008-06-27T06:21:00.007-05:00

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.