Beyond Advertising-The Pharmaceutical Industry's Hidden Marketing Tactics: - Targeting doctors: - Turning patients into consumers: 2/23/08 Post on Tony's site today

[Guest guest]

From a silent sister . . . Just proves how far they've sunk! . . . Money over life! . . . - Rogene

Beyond

Advertising-The Pharmaceutical Industry's Hidden Marketing Tactics: 2008 In

early January, the U.S. House Committee on Energy and Commerce

began investigating celebrity endorsements in television ads for brand-name

drugs. The investigation was sparked by Pfizer's commercials for its best-selling cholesterol drug Lipitor.

These direct-to-consumer (DTC) ads

feature Dr. Jarvik, a pioneer in the development of the artificial

heart. Viewers are not told that Jarvik is not a cardiologist, nor is he

licensed to practice medicine. His presentation as a trusted expert, Pfizer

presumably hopes, is enough to persuade viewers to ask their doctors for

Lipitor by name. And that would help erode the increasing competition from

generic alternatives. DTC

ads have been controversial since the Food and Drug Administration

(FDA) loosened the rules governing pharmaceutical marketing in 1997. Before

Lipitor made headlines, there was Viagra. Pfizer's "Viva Viagra!"

campaign was criticized by the FDA and organizations including the AIDS

Healthcare Foundation, who said the DTC ads encouraged recreational use of the

erectile dysfunction drug. One print ad suggested that Viagra be used to

"celebrate" events such as the Super Bowl or New Year's Eve. While

troubling, DTC ads represent only 14 percent of pharmaceutical companies'

marketing budgets. By the time a 30-second drug commercial airs, the company

has conducted months of segmentation studies, held dozens of meetings to define

the "communication target" (typically a woman, usually a mother, and

of a certain income), and spent millions of dollars to develop the drug's brand

and its market. This strategic marketing, which represents the remaining 86

percent of drug promotion expenses, should receive at least as much attention

from regulators and lawmakers as DTC ads. Targeting

doctors:

While DTC ads seek to change patients' behavior, pharmaceutical companies are

more interested in changing doctors' behavior. Drug marketers work hard to

persuade doctors to prescribe their branded drug over generics and other

competitors, and to change other medical practices that limit company profits. To

cultivate medical professionals, drug companies may retain a doctor as a

spokesperson, position friendly medical "thought-leaders" in the

media, or organize free events at posh resorts and expensive hotels to

"educate" doctors about a new disease state (think Restless Leg

Syndrome) or their latest drug. In 2000, the biggest 10 pharmaceutical

companies spent $1.9 billion on promotional events alone. Then

there is the pharmaceutical industry's holy grail of marketing -- the

relationship between their sales representatives and medical doctors. To

maintain this relationship, often called "detailing," pharmaceutical

companies spend a whopping $8,290 per doctor. The average family doctor

receives 28 visits each week from drug reps, who provide free samples, explain

new findings from company-sponsored drug trials, and demonstrate the latest

innovation in their company’s medical devices. Some

doctors, reporters and public health advocates have long decried the

pharmaceutical industry's seemingly endless attempts to buy goodwill among

medical professionals. But insidious marketing campaigns seeking to rebrand

medical conditions as lifestyle choices, and the patients who suffer from them

as consumers, have received little scrutiny. Turning

patients into consumers:

How are patients turned into consumers? The rebranding of Prozac, pharma giant Eli Lilly's top-selling antidepressant,

as Sarafem illustrates the process. Sarafem

and Prozac are chemically identical. The only differences between the two drugs

are branding -- Prozac is yellow and green, Sarafem is pink and purple -- and

what each is prescribed for. Prozac is used to treat an array of symptoms

associated with depression, while Sarafem is used to treat a highly contested

and little recognized condition known as premenstrual dysphoric disorder

(PMDD). By

going back to the FDA and getting approval to use Prozac to treat a new set of

symptoms, Eli Lilly won big. The company now has two separate markets to sell

to, and it stymied potential generic competitors to boot. Sarafem hit the

market in late 2000, just months before Eli Lilly's patent on Prozac ran out.

Sarafem's introduction effectively extended the patent on Prozac. Rebranding

is a highly effective marketing strategy. First of all, the process is mostly

hidden from the "communication target": the person looking at a drug

ad. Ads for a rebranded drug don't mention that the only thing "new"

about the drug is the color of its coating. In addition, expanding the drug's

FDA approval to cover new, ill-defined medical conditions allows the

pharmaceutical company to decide who might benefit from their product. Not

surprisingly, their definitions tend to be wide ranging, even including what

are usually considered normal experiences. For example, Eli Lilly includes

among its symptoms of PMDD

"irritability, mood swings, tension as well as breast tenderness and

bloating" in the week before a woman’s menstrual period. "Left

untreated, [PMDD] can get worse with age," warns the drugmaker. At least

until menopause, that is. Rebranding

isn’t just for pills -- medical devices are a hot area for this marketing

technique. Medical devices refer to everything from wheelchairs and contact

lenses to artificial hips and breast implants. Also included in this category

are the new skin "fillers," which are injected under the skin to

smooth out wrinkles. The

market for injectable fillers has exploded since 2003, after the FDA approved

Restylane™ for use under the skin between the nose and mouth, to smooth

out smile lines. Since then, at least 13 more injectable fillers have hit the

market, with several more in clinical trials. All are promoted as non-surgical

alternatives to facelifts or as longer-lasting wrinkle treatments than the

injectable neurotoxin Botox™. Non-surgical

cosmetic procedures represent an enormous market potential. According to the American Society of Aesthetic Plastic Surgery (PDF),

in 2006 Americans spent close to $12.2 billion on elective cosmetic procedures.

That same year, the number of cosmetic plastic surgeries decreased for the

first time since 1997, while non-surgical procedures increased nearly

eight-fold. Non-surgical procedures account for 83 percent of the 11.5 million

cosmetic procedures done in the United

States alone, and injectable fillers are

second only to Botox™ as the most popular cosmetic procedure performed on

the face. Many

of these new gels and fillers were initially developed and approved for medical

applications, such as in dissolvable sutures, to relieve joint pain or to

repair eye damage. Then, they were rebranded for cosmetic applications. Two of

the fillers still have FDA approval for medical applications only: Silikon

1000® for retinal treatments, and Sculptra® to treat facial fat loss in

HIV-positive patients on anti-retroviral drug therapies. But both are marketed

to consumers and doctors for "off-label," or unapproved, cosmetic

purposes. The

FDA does not regulate off-label use of drugs or medical devices. The agency

sees its role narrowly as a regulatory body, and believes off-label practices

help foster medical advances. It is illegal to promote off-label uses in DTC

advertisements, but off-label uses are marketed in other, more subtle ways. The

ad for Restylane, for example, cannot mention its off-label applications, but

marketers continually promote these unapproved uses. The off-label marketing of

drugs and medical devices raises serious questions. Turning

medical necessities into consumer choices:

The December 2007 issues of the women’s fashion magazines Allure and Harper's Bazaar both featured multi-page spreads on

non-surgical cosmetic procedures, including the array of injectable wrinkle

fillers. The articles outlined the pros and cons of each filler, evaluating

injection pain, cost per injection (most run between $500 and $800 per shot),

and how long each lasts. Dermatologist

and anti-aging cream entrepreneur Dr. Wexler is

featured prominently in the Bazaar

story. Her remarks about each injectable reflect the marketing language of the

brands themselves. When she is discussing Sculptra®, for instance, she

describes how the product acts as "a trellis on which the collagen can

grow" -- a line marketers use to describe how the device works. She also

repeatedly suggests what are off-label, unregulated product applications, such

as using injectable fillers in the eye area, in the temples, in the jawline, on

the cheekbones, and in the fine lines surrounding the mouth. Much

like Dr. Jarvik's pitches for Lipitor, Dr. Wexler's injectable filler

promotions are especially credible among the target audience. Wexler regularly

discusses non-invasive, anti-aging procedures on the "Oprah Winfrey

Show," the "Today Show," and "Good Morning America,"

and in the pages of Vogue and Marie . The big pharma companies

that make the injectable fillers likely dream of doctors touting their products

and suggesting off-label uses for them in popular women's magazines. As the

saying goes, they couldn't buy such good press -- but they probably did. These

articles, as well as the latest DTC television ad for Restylane™, clearly

encourage off-label use of injectable fillers. Since the FDA has not approved

these uses, they haven't been properly tested in clinical trials. For example,

Sculptra was only tested in one trial, on 279 white, HIV-positive men. The

filler has never undergone clinical trials on HIV-negative people, on people of

color, or on anyone's hands or foreheads. People who use the fillers in these

ways are effectively acting as guinea pigs. Not surprisingly, there have been

reports of adverse affects in people with healthy immune systems. Earlier this

month, USA Today

reported that the FDA is now warning patients who use off-label Botox

injections that they risk serious adverse side effects, including death. While

the FDA officially considers off-label use as spontaneous, observation-driven

and innovative medical practice, the truth is that promoting off-label

applications is a calculated marketing tactic to increase sales. With the

injectable fillers, these semi-covert promotions have been quickly accepted by

doctors and the general public, making off-label use the norm. Such marketing

efforts are increasingly blurring the distinction between medical innovations

and sales pitches. Worse, the trend is seriously undermining the regulatory

authority of the FDA. It's

not surprising that profit-driven, cutting-edge marketing techniques have

outstripped the government agency established to guide them. What is surprising

is that public health advocates haven't made pharmaceutical rebranding and

off-label promotions of drugs and medical devices major issues. In December,

the advocacy group Consumers Union sent to the FDA requesting tighter DTC

advertising regulations on medical devices. That's a good first step, but much

more must be done. References:

Bonnie Goldstein,

"Dr. Jarvik, Pitchman,"

Slate.com, Jan. 10, 2008.

Saul, "Drug Ads Raise Questions for Heart

Pioneer," The New

York Times, Feb. 7, 2008.

Herper, "Best-Selling Drugs in America,"

Forbes, Feb. 26, 2006. "Pfizer's 'Viva Viagra' Ads Promote Party

Use, Says AHF," Backchannelmedia.com, July 24, 2007. "FDA Warns Pfizer About Celebrex Ad

Claims, 27 Minute Infomercial Mentioned,"

Backchannelmedia.com, Jan. 13, 2005.

McGuire, "Statin Market Roiled as Generic Zocor Bites Lipitor," Medical Marketing & Media, October

2007. Val

Brickates Kennedy, "Pfizer's profit plunges on generic

competition," MarketWatch.com, July 18, 2007.

Donohue, Marisa Cevasco, and Meredith Rosenthal, "A Decade of Direct-to-Consumer Advertising of Prescription

Drugs," New England

Journal of Medicine, Vol. 357:673-681, Aug. 16, 2007.

Vivian, "What’s In a Name?"

U.S. Pharmacist, Sept. 13, 2002. Rita

Rubin, "Off-label Botox linked to serious

side-effects," USA

Today, Feb. 11, 2008. Amy

Newburger, "Cosmetic Medical Devices and their FDA Regulations," Archives of Dermotology, Vol. 142:225-228,

Feb. 2006. Consumers

Union, "Prescription for Change: Detailing," Consumers

Union , March 2006. Marc-André

Gagnon and Lexchin, "The Cost of Pushing Pills: A New Estimate of

Pharmaceutical Promotion Expenditures in the

United States ," PLoS, Vol.

5(1) Jan. 2008. FDA warning letter to Eli Lilly

concerning DTCA of Sarafem, Nov. 11, 2000.

Ebeling is an Assistant Professor of Sociology in the Department

of Culture and Communication at Drexel University in

Philadelphia , Pennsylvania .

Her research focuses on emerging technologies and the construction of

technological markets.

[Guest guest]

From a silent sister . . . Just proves how far they've sunk! . . . Money over life! . . . - Rogene

Beyond

Advertising-The Pharmaceutical Industry's Hidden Marketing Tactics: 2008 In

early January, the U.S. House Committee on Energy and Commerce

began investigating celebrity endorsements in television ads for brand-name

drugs. The investigation was sparked by Pfizer's commercials for its best-selling cholesterol drug Lipitor.

These direct-to-consumer (DTC) ads

feature Dr. Jarvik, a pioneer in the development of the artificial

heart. Viewers are not told that Jarvik is not a cardiologist, nor is he

licensed to practice medicine. His presentation as a trusted expert, Pfizer

presumably hopes, is enough to persuade viewers to ask their doctors for

Lipitor by name. And that would help erode the increasing competition from

generic alternatives. DTC

ads have been controversial since the Food and Drug Administration

(FDA) loosened the rules governing pharmaceutical marketing in 1997. Before

Lipitor made headlines, there was Viagra. Pfizer's "Viva Viagra!"

campaign was criticized by the FDA and organizations including the AIDS

Healthcare Foundation, who said the DTC ads encouraged recreational use of the

erectile dysfunction drug. One print ad suggested that Viagra be used to

"celebrate" events such as the Super Bowl or New Year's Eve. While

troubling, DTC ads represent only 14 percent of pharmaceutical companies'

marketing budgets. By the time a 30-second drug commercial airs, the company

has conducted months of segmentation studies, held dozens of meetings to define

the "communication target" (typically a woman, usually a mother, and

of a certain income), and spent millions of dollars to develop the drug's brand

and its market. This strategic marketing, which represents the remaining 86

percent of drug promotion expenses, should receive at least as much attention

from regulators and lawmakers as DTC ads. Targeting

doctors:

While DTC ads seek to change patients' behavior, pharmaceutical companies are

more interested in changing doctors' behavior. Drug marketers work hard to

persuade doctors to prescribe their branded drug over generics and other

competitors, and to change other medical practices that limit company profits. To

cultivate medical professionals, drug companies may retain a doctor as a

spokesperson, position friendly medical "thought-leaders" in the

media, or organize free events at posh resorts and expensive hotels to

"educate" doctors about a new disease state (think Restless Leg

Syndrome) or their latest drug. In 2000, the biggest 10 pharmaceutical

companies spent $1.9 billion on promotional events alone. Then

there is the pharmaceutical industry's holy grail of marketing -- the

relationship between their sales representatives and medical doctors. To

maintain this relationship, often called "detailing," pharmaceutical

companies spend a whopping $8,290 per doctor. The average family doctor

receives 28 visits each week from drug reps, who provide free samples, explain

new findings from company-sponsored drug trials, and demonstrate the latest

innovation in their company’s medical devices. Some

doctors, reporters and public health advocates have long decried the

pharmaceutical industry's seemingly endless attempts to buy goodwill among

medical professionals. But insidious marketing campaigns seeking to rebrand

medical conditions as lifestyle choices, and the patients who suffer from them

as consumers, have received little scrutiny. Turning

patients into consumers:

How are patients turned into consumers? The rebranding of Prozac, pharma giant Eli Lilly's top-selling antidepressant,

as Sarafem illustrates the process. Sarafem

and Prozac are chemically identical. The only differences between the two drugs

are branding -- Prozac is yellow and green, Sarafem is pink and purple -- and

what each is prescribed for. Prozac is used to treat an array of symptoms

associated with depression, while Sarafem is used to treat a highly contested

and little recognized condition known as premenstrual dysphoric disorder

(PMDD). By

going back to the FDA and getting approval to use Prozac to treat a new set of

symptoms, Eli Lilly won big. The company now has two separate markets to sell

to, and it stymied potential generic competitors to boot. Sarafem hit the

market in late 2000, just months before Eli Lilly's patent on Prozac ran out.

Sarafem's introduction effectively extended the patent on Prozac. Rebranding

is a highly effective marketing strategy. First of all, the process is mostly

hidden from the "communication target": the person looking at a drug

ad. Ads for a rebranded drug don't mention that the only thing "new"

about the drug is the color of its coating. In addition, expanding the drug's

FDA approval to cover new, ill-defined medical conditions allows the

pharmaceutical company to decide who might benefit from their product. Not

surprisingly, their definitions tend to be wide ranging, even including what

are usually considered normal experiences. For example, Eli Lilly includes

among its symptoms of PMDD

"irritability, mood swings, tension as well as breast tenderness and

bloating" in the week before a woman’s menstrual period. "Left

untreated, [PMDD] can get worse with age," warns the drugmaker. At least

until menopause, that is. Rebranding

isn’t just for pills -- medical devices are a hot area for this marketing

technique. Medical devices refer to everything from wheelchairs and contact

lenses to artificial hips and breast implants. Also included in this category

are the new skin "fillers," which are injected under the skin to

smooth out wrinkles. The

market for injectable fillers has exploded since 2003, after the FDA approved

Restylane™ for use under the skin between the nose and mouth, to smooth

out smile lines. Since then, at least 13 more injectable fillers have hit the

market, with several more in clinical trials. All are promoted as non-surgical

alternatives to facelifts or as longer-lasting wrinkle treatments than the

injectable neurotoxin Botox™. Non-surgical

cosmetic procedures represent an enormous market potential. According to the American Society of Aesthetic Plastic Surgery (PDF),

in 2006 Americans spent close to $12.2 billion on elective cosmetic procedures.

That same year, the number of cosmetic plastic surgeries decreased for the

first time since 1997, while non-surgical procedures increased nearly

eight-fold. Non-surgical procedures account for 83 percent of the 11.5 million

cosmetic procedures done in the United

States alone, and injectable fillers are

second only to Botox™ as the most popular cosmetic procedure performed on

the face. Many

of these new gels and fillers were initially developed and approved for medical

applications, such as in dissolvable sutures, to relieve joint pain or to

repair eye damage. Then, they were rebranded for cosmetic applications. Two of

the fillers still have FDA approval for medical applications only: Silikon

1000® for retinal treatments, and Sculptra® to treat facial fat loss in

HIV-positive patients on anti-retroviral drug therapies. But both are marketed

to consumers and doctors for "off-label," or unapproved, cosmetic

purposes. The

FDA does not regulate off-label use of drugs or medical devices. The agency

sees its role narrowly as a regulatory body, and believes off-label practices

help foster medical advances. It is illegal to promote off-label uses in DTC

advertisements, but off-label uses are marketed in other, more subtle ways. The

ad for Restylane, for example, cannot mention its off-label applications, but

marketers continually promote these unapproved uses. The off-label marketing of

drugs and medical devices raises serious questions. Turning

medical necessities into consumer choices:

The December 2007 issues of the women’s fashion magazines Allure and Harper's Bazaar both featured multi-page spreads on

non-surgical cosmetic procedures, including the array of injectable wrinkle

fillers. The articles outlined the pros and cons of each filler, evaluating

injection pain, cost per injection (most run between $500 and $800 per shot),

and how long each lasts. Dermatologist

and anti-aging cream entrepreneur Dr. Wexler is

featured prominently in the Bazaar

story. Her remarks about each injectable reflect the marketing language of the

brands themselves. When she is discussing Sculptra®, for instance, she

describes how the product acts as "a trellis on which the collagen can

grow" -- a line marketers use to describe how the device works. She also

repeatedly suggests what are off-label, unregulated product applications, such

as using injectable fillers in the eye area, in the temples, in the jawline, on

the cheekbones, and in the fine lines surrounding the mouth. Much

like Dr. Jarvik's pitches for Lipitor, Dr. Wexler's injectable filler

promotions are especially credible among the target audience. Wexler regularly

discusses non-invasive, anti-aging procedures on the "Oprah Winfrey

Show," the "Today Show," and "Good Morning America,"

and in the pages of Vogue and Marie . The big pharma companies

that make the injectable fillers likely dream of doctors touting their products

and suggesting off-label uses for them in popular women's magazines. As the

saying goes, they couldn't buy such good press -- but they probably did. These

articles, as well as the latest DTC television ad for Restylane™, clearly

encourage off-label use of injectable fillers. Since the FDA has not approved

these uses, they haven't been properly tested in clinical trials. For example,

Sculptra was only tested in one trial, on 279 white, HIV-positive men. The

filler has never undergone clinical trials on HIV-negative people, on people of

color, or on anyone's hands or foreheads. People who use the fillers in these

ways are effectively acting as guinea pigs. Not surprisingly, there have been

reports of adverse affects in people with healthy immune systems. Earlier this

month, USA Today

reported that the FDA is now warning patients who use off-label Botox

injections that they risk serious adverse side effects, including death. While

the FDA officially considers off-label use as spontaneous, observation-driven

and innovative medical practice, the truth is that promoting off-label

applications is a calculated marketing tactic to increase sales. With the

injectable fillers, these semi-covert promotions have been quickly accepted by

doctors and the general public, making off-label use the norm. Such marketing

efforts are increasingly blurring the distinction between medical innovations

and sales pitches. Worse, the trend is seriously undermining the regulatory

authority of the FDA. It's

not surprising that profit-driven, cutting-edge marketing techniques have

outstripped the government agency established to guide them. What is surprising

is that public health advocates haven't made pharmaceutical rebranding and

off-label promotions of drugs and medical devices major issues. In December,

the advocacy group Consumers Union sent to the FDA requesting tighter DTC

advertising regulations on medical devices. That's a good first step, but much

more must be done. References:

Bonnie Goldstein,

"Dr. Jarvik, Pitchman,"

Slate.com, Jan. 10, 2008.

Saul, "Drug Ads Raise Questions for Heart

Pioneer," The New

York Times, Feb. 7, 2008.

Herper, "Best-Selling Drugs in America,"

Forbes, Feb. 26, 2006. "Pfizer's 'Viva Viagra' Ads Promote Party

Use, Says AHF," Backchannelmedia.com, July 24, 2007. "FDA Warns Pfizer About Celebrex Ad

Claims, 27 Minute Infomercial Mentioned,"

Backchannelmedia.com, Jan. 13, 2005.

McGuire, "Statin Market Roiled as Generic Zocor Bites Lipitor," Medical Marketing & Media, October

2007. Val

Brickates Kennedy, "Pfizer's profit plunges on generic

competition," MarketWatch.com, July 18, 2007.

Donohue, Marisa Cevasco, and Meredith Rosenthal, "A Decade of Direct-to-Consumer Advertising of Prescription

Drugs," New England

Journal of Medicine, Vol. 357:673-681, Aug. 16, 2007.

Vivian, "What’s In a Name?"

U.S. Pharmacist, Sept. 13, 2002. Rita

Rubin, "Off-label Botox linked to serious

side-effects," USA

Today, Feb. 11, 2008. Amy

Newburger, "Cosmetic Medical Devices and their FDA Regulations," Archives of Dermotology, Vol. 142:225-228,

Feb. 2006. Consumers

Union, "Prescription for Change: Detailing," Consumers

Union , March 2006. Marc-André

Gagnon and Lexchin, "The Cost of Pushing Pills: A New Estimate of

Pharmaceutical Promotion Expenditures in the

United States ," PLoS, Vol.

5(1) Jan. 2008. FDA warning letter to Eli Lilly

concerning DTCA of Sarafem, Nov. 11, 2000.

Ebeling is an Assistant Professor of Sociology in the Department

of Culture and Communication at Drexel University in

Philadelphia , Pennsylvania .

Her research focuses on emerging technologies and the construction of

technological markets.