# Presentation: 252973

## Pat Kelly
President, US Pharmaceuticals
Pfizer Inc
Presented at the FDA DTC Public Hearing
November 1, 2005

- President, US Pharmaceuticals
- Pfizer Inc
*Presented at the FDA DTC Public Hearing*
*November 1, 2005*

***Advancing Public Health Through Effective Consumer Health Communication***

**Notes:**
[SLIDE 1 – Title]
Good [morning/afternoon], I’m Pat Kelly, president of Pfizer U.S. Pharmaceuticals.  Thank you for inviting me to participate on this panel to address the important topic of direct-to-consumer advertising of prescription medicines.  We’ll also be submitting written comments to the hearing docket.
As a representative of Pfizer – and the pharmaceutical industry more broadly – I believe that informed dialogue between patients and healthcare providers is the single most important element of healthcare communications.

## Communicating with Consumers

***Communicating with Consumers***

**Patient/Healthcare Provider ****Partnership**** **

**Motivating ****Actions**

**Appropriate Diagnosis and Treatment**

- To communicate motivating, useful and understandable information about medical conditions and treatment options . . . ***to help patients work with their healthcare providers to make more informed decisions about their health, which leads to needed diagnoses, appropriate treatment and better health outcomes.***

***Pfizer’s Consumer Communication***

**Notes:**
[SLIDE 2 ALTERNATE – Pfizer’s consumer communications mission]
One of Pfizer’s greatest responsibilities – to our customers and our business – is to communicate information about medical conditions and our products in ways that enable the best health outcomes possible. 
We believe - and research supports - that direct communication with consumers . . . and, more specifically, DTC advertising . . . is an important and effective channel for this information.  Further, we believe that DTC advertising helps patients work with their healthcare providers to make more informed decisions about their health . . .  which, in turn, leads to needed diagnoses, appropriate treatment and, ultimately, better health outcomes.  

## Millions Are Undiagnosed and Untreated

***Millions Are Undiagnosed and Untreated***

- 54 million more Americans need treatment for high cholesterol
- 25 million undiagnosed/ untreated for high blood pressure
- 10 million undiagnosed/ untreated for diabetes

**35 million**

**19 million**

**High Cholesterol **

**Notes:**
[SLIDE 3 – Millions are undiagnosed and untreated...]
This point is especially important because there are tens of millions of Americans who are undiagnosed, untreated or under-treated for medical conditions that could be treated if they were aware of these conditions or motivated to seek help.   These include such serious conditions as high cholesterol, diabetes, depression, high blood pressure and asthma.  
For example, today some 35 million Americans don’t know they suffer from high cholesterol.  And 19 million do know they have this condition but aren’t being treated for it.  Here you can see the number of those untreated for high blood pressure and diabetes.

## Strong Record of Public Health Benefits

***Strong Record of Public Health Benefits***

- To become more aware
- To seek information
- To seek diagnosis and treatment

***Motivation***

***Engagement***

***Commitment***

- Interaction with a healthcare professional

- Persistence on therapy

**Notes:**
[SLIDE 4 – Research demonstrates public health benefits of DTC advertising]
Research has shown that DTC advertising raises awareness of medical conditions and motivates people to seek information, diagnosis and treatment; encourages consumers to talk to their healthcare providers about benefits and risks; and helps them to stay engaged in caring for their health care.  

## DTC Advertising Serves Public Health

- Delivers important information to patients according to patients themselves1
- Motivates people to seek additional health information2
- Encourages people to act on the information they receive and speak with their physicians3
- Promotes conversations that result in new diagnoses of important conditions4

- 1 Source: Prevention Magazine Annual Survey, 2004,
- 2 Sources: Harvard/Harris Study, 2002; FDA Patient Survey, 2002
- 3 Sources: Prevention Magazine Annual Survey, 2004; FDA Patient Survey, 2002; Harvard/Harris Study, 2002
- 4 Source: Harvard/Harris Study, 2002

**Notes:**
[SLIDE 5 – DTC advertising motivates information seeking]
Study after study has shown that:
DTC advertising delivers important information to patients, according to patients themselves.   In Prevention magazine’s annual study, 80 percent or more of the public reports that ads encourage them to find out more about the conditions the advertising treats . . . and that the ads alert them to symptoms of conditions that they might have.
DTC advertising is motivating people to seek additional health information.   The 2002 FDA Patient Survey found that 43 percent of consumers report that a DTC ad has moved them to find more information.
The information people receive through DTC advertising motivates them to speak to their physicians.   A GAO review of DTC studies showed an average of 33 percent of consumers have talked to their physicians about an advertised medicine because of an ad. 
And advertising-driven conversations result in new diagnoses of important conditions.   A Harris Interactive/Harvard DTC study showed that 25 percent of advertising-driven conversations resulted in new diagnoses, nearly half of which were for “high priority” conditions, as defined by AHRQ/IQM criteria.

## Patients Are Motivated to Speak with Physician

- 29 million consumers have talked to their physicians about a health condition for the first time because of an ad.1

***Patients Are Motivated to Speak with Physician***

- 1 Prevention Magazine, “8th Annual Survey of Consumer Reaction to Direct-to-Consumer Advertising of Prescription Medications”, 2005

***Prevention Magazine Study ***

**Notes:**
[SLIDE 6 – Patients are motivated to speak with a physician]
According to the 2004 Prevention magazine survey, more than 65 million patients have talked with their physicians after seeing a DTC advertisement.  And 29 million of these patients mentioned a condition to their doctor for the first time. 

## Advertising Leads to New Diagnoses

***Advertising Leads to New Diagnoses***

- 43% of diagnoses were “high priority” conditions, according to AHRQ/IOM criteria:
- Diabetes
- High Cholesterol
- Hypertension
- Depression
- Asthma
- Arthritis
- Anxiety

- NoDiagnosis

**46%**

**25%**

**20%**

- New Diagnosis

- Conversation Was About Existing Condition

- Missing/Unknown

**9%**

- Source: Harvard/Harris Interactive Study, 2002

***Diagnoses***

**Notes:**
[SLIDE 7 – Advertising-driven conversations are resulting in...]
DTC advertising has helped one in four patients who asked about a DTC advertised product during a doctor visit receive a diagnosis for a previously unknown medical condition.  And more than 40 percent of these new diagnoses were for such high priority conditions as diabetes, high blood pressure and asthma.  
In other words, DTC advertising motivates millions of people who need treatment to get treatment . . . improving patient health, strengthening our nation’s health and reducing healthcare costs long-term.   
This enormous public health benefit notwithstanding, we fully understand that critics have serious concerns about how pharmaceutical companies communicate product-related messages to consumers.  They question whether promotional messages can accurately provide product information. They also question the appropriateness of the medication utilization that may result. [MICHAL: THIS POINT STILL NEEDS TO BE ADDRESSED, OR WE NEED TO DROP THE RERENCE TO “UTILIZATION.”]
In addition to the third-party research I’ve cited here, over the nearly eight years we have communicated directly with consumers . . . we have regularly conducted our own health care survey research . . . and consulted with patients and healthcare providers . . . to learn how we can improve the value – to both patients and providers – of this important health information channel.
Through this research, we’ve learned much about consumers’ health information needs and how DTC advertising can have a greater impact on healthy behavior.  Specifically, we’ve learned that:

## Motivating Consumers to Overcome Barriers 

- Lack of awareness and understanding
- Denial
- Misinformation
- Low health literacy
- Perceived stigma
- Lack of insurance

**Notes:**
[SLIDE 8 – Patient barriers]
Ads need to provide information that motivates consumers to overcome the significant barriers that continue to prevent millions of Americans from seeking information . . . or starting that all-important conversation with their doctor to get the medical help they need.  The barriers range from lack of awareness to denial and misinformation to low health literacy, perceived stigma and lack of insurance coverage.  And this is true across all disease areas. 

## Driving Consumers to Learn More 

- Conversation with physician
- Magazines/newspapers
- Conversations with friends/family
- Conversation with pharmacist
- TV ads
- Conversation with nurse
- Materials in Dr’s office
- General health websites
- Magazine/newspaper ads
- Info from hospital/health clinic
- Info from pharmacy
- Health-related newsletter

- BASE: Rep. Respondents n = 3936
- Q4a Please indicate which of the following you have experienced in the past month OR the past year.
- Q4b For each information source you “X’d” in Q4a, in the past year, how many times have you experienced each?
- * Anything under 10% not shown

*** ******Top-Information Sources***
***(Ranking Based Past-year Usage*)***

***Accessing 4 to 5 Information Sources on Average            Per Condition***

**Notes:**
[SLIDE 9 – Suffers seek health information from a variety of sources]
DTC advertising is – and should remain – a catalyst that drives consumers to get the full depth of information about prescription medicines, something they pursue through a variety of sources, including their healthcare providers.  We know consumers use a variety of information sources, including DTC advertising, at various points to become motivated, engaged and committed to better health.  For example, our research shows that the average patient consults four to five different information sources to understand his or her condition and engage in his or her health care.   In addition to DTC advertising, patients seek information from sources as diverse as conversations with a physician, as well as friends and family; the Internet, and health-related newsletters.  And this makes clear that there is no single health information paradigm. The search for information and usage by patients varies by condition, as well as by patient type.   
DTC advertising is not – and should not be viewed as – a comprehensive health information source that leads consumers to think they don’t need any more information.  We need to recognize what this advertising can do and what it can’t do.  DTC advertising can help consumers by providing important information about risks and benefits to help them determine whether the treatment option advertised might be right for them . . . and it can motivate them to seek additional information and/or consult their healthcare provider.  But it cannot and should not be seen or treated as a comprehensive source of health information, one that might deter them from consulting their healthcare provider. 

## Consumers Need Understandable Information 

- Focused communication objectives
- Consistent message across channels
- Credible and objective
- Culturally relevant
- Interactive
- Engaging

***Pfizer Clear Health Communication Principles***

**Notes:**
[SLIDE 10 – Consumers need and want accessible, understandable health information]
Health information needs to be accessible and understandable.  Our experience has shown that patients – and potential patients – often lack basic knowledge of medical conditions, treatments and medications.    While we know that 87 percent of patients are aware that prescription medications come with risks that must be discussed with their physicians,  they often lack basic knowledge of the medication’s specific indications and risks.  
And our research has shown that consumers cannot easily understand medical information.  So, information that some might consider “too basic” might be just the right impetus for that important conversation with a healthcare provider.  To address consumers’ needs for easier-to-read and easier-to-understand health information, we have developed and apply to all of our consumer print communications – including our ads – Clear Health Communications Principles that ensure that all of these materials are written and understandable at the 6th-grade reading level.

## Consumers are Understanding Risk

- Source:  Prevention Magazine, 8th Annual Survey of Consumer Reaction to Direct-to-Consumer Advertising of Prescription Medicines.  Telephone interviews of nationally representative sample of 1,504 Adults Age 18+, December 28, 2004- January 12, 2005

- Base: Consumers Who Saw/Heard DTC Ads

***Consumer Awareness of Benefit & Risk Information in DTC TV Ads***

- 2003

- 2004

- 2003

- 2004

***DTC and Risk Communication***

**Notes:**
[SLIDE 11 – DTC and risk communication]
DTC ads are communicating important risk information.  We cannot under-inform or over-deter consumers from taking action to better health.   According to a Prevention survey on DTC advertising, completed in January of 2005,  79 percent of those surveyed recalled that risk information was included in prescription drug TV advertisements.  The vast majority [HOW MANY?] of these respondents said that this information was useful.  At the same time, 75 percent recalled that benefit information was included.  Both numbers are up, as you can see, from the prior year’s levels.  

## Consumers are Understanding Risk (cont'd.)

- Significant increases in the perceptions of the “seriousness” of side effects among those who viewed an ad (vs. an unexposed control cell)
- Significant increases in recognition of specific side effects among those who viewed an ad (vs. an unexposed control cell)

- 40% of respondents who view a branded ad report that information in the ad “raised concerns about using the advertised product”

- 1 See Kaiser Family Foundation, “Understanding the Effects of Direct-to-Consumer Prescription Drug Advertising”, November 2001.  Methodology:  Forced exposure ad testing of TV ads for three brands (Lipitor; Nexium; Singular).  Random sample of ~ 600 people viewed each ad.  Unexposed cell (Random sample of ~600 people) used as a control to gauge ingoing risk and benefit knowledge
- 2 Based on a custom analysis requested by Pfizer of a major advertising research vendor’s “full product” branded Rx database of over 400 commercials

***Experience with Testing Actual Ads***

***Ad viewers show increased recognition and perceptions******of risks******1***

***Ad viewers take the risk information in ads seriously******2***

**Notes:**
[SLIDE 12 – DTC and risk communication (cont'd.)]
In more controlled settings, TV and print ads have been shown to significantly increase risk perceptions ???and communication???, based on comparisons of people who viewed specific ads vs. control groups of people who had not.  Testing has repeatedly shown significant increases among those who viewed an ad in:
The perceptions of the overall “seriousness” of side effects (For example, 70 percent of viewers of a Lipitor ad reported that the medicine had very or somewhat serious side effects vs. 18 percent of non-viewers.);
Recognition of specific side effects (Correct recognition that Lipitor could cause liver problems was 74 percent among viewers of an ad vs. 18 percent among non-viewers); and
Recognition of who should not take the advertised medicine (An average of 40 percent of those who viewed a branded ad reported that information in the ad “raised concerns about using the advertised product.”)

## Importance of Patient-Provider Partnership 

- Best healthcare decisions result from:
- Consultation
- Engagement
- Mutual Determination
- Decision to prescribe medicine *is still the* *physician’s alone.*

**Notes:**
[SLIDE 8 – Patient barriers]
Ads need to provide information that motivates consumers to overcome the significant barriers that continue to prevent millions of Americans from seeking information . . . or starting that all-important conversation with their doctor to get the medical help they need.  The barriers range from lack of awareness to denial and misinformation to low health literacy, perceived stigma and lack of insurance coverage.  And this is true across all disease areas. 

## We Can Do Better 

- Encourage dialogue between patients and  healthcare providers
- Help consumers better understand the risks and benefits of prescription medicines
- Continue to motivate people to overcome potential barriers to better health

**Notes:**
[SLIDE 8 – Patient barriers]
Ads need to provide information that motivates consumers to overcome the significant barriers that continue to prevent millions of Americans from seeking information . . . or starting that all-important conversation with their doctor to get the medical help they need.  The barriers range from lack of awareness to denial and misinformation to low health literacy, perceived stigma and lack of insurance coverage.  And this is true across all disease areas. 

## Pfizer Advertising Improvement Examples

***Encourage Diet and Exercise***

***Easy to Understand***

***Assistance for Patients Navigating Healthcare System***

**Notes:**
[SLIDE 14 – Pfizer advertising improvement examples]
In addition:
Our branded TV and print ads and product Web sites now include language informing patients that their doctors may recommend alternative treatments, such as diet, exercise or other medicines, and that only their doctor “knows what’s right for you.”  
We’re no longer running ads that do not include the indication, benefits and risks associated with the advertised medicine.  
We’ll begin using a new consumer-friendly and consumer-tested print brief summary with FDA approval.
We’ll fund research to find ways to further improve risk communication in DTC TV advertising.  We’re seeking input on this research from the FDA and third parties and will adjust Pfizer’s communications based on the results.
And we’re running an ad campaign devoted to our comprehensive prescription assistance program, Pfizer Helpful Answers, that includes information on how to access Pfizer medicines as well as the broad industry assistance program.  

## Recommendations 

- Don’t sacrifice proven public health benefits of DTC
- Pursue changes in an evidence-based way
- Critical research is needed
- Work together to ensure that communications are truly helpful, understandable and engaging to the patient
- Focused
- Balanced
- Expand rather than reduce information options
- Help consumers work with their healthcare providers
- Recognize people’s barriers to healthy behavior and the importance of DTC in overcoming them

**Notes:**
[SLIDE 15 – Recommendations]
As the FDA considers how to maximize the benefits of DTC advertising, we urge the health care community to step back from the heat of the current debate, recognize the changes that the industry has made and allow the impact of these changes to take hold.  
And we urge the FDA to consider these important factors when assessing the need for any changes to current advertising guidelines:  
Millions of Americans are undiagnosed, untreated or under-treated.  The record shows that that DTC advertising  benefits consumers and healthcare more broadly . . .by raising consumer awareness and prompting Americans to have important conversations with their healthcare providers. . . that can lead to early diagnosis and appropriate treatment of serious health issues.  Let’s not sacrifice these proven public health benefits with changes that are not based on research about what consumers need to take healthy action.
Medical information is complex and confusing, coming from regulated and unregulated sources.  It’s critical to provide information about prescription medicines to consumers in a way that is clear, understandable and accurate.  This includes providing the most important information about risk and benefit and the most life-threatening information.  We take this responsibility very seriously. 
With this in mind, we need more research on just how to define empirical contours of a legally “loaded” term such as “misleading” when applied to DTC advertising.  The evidence proves that DTC advertising is highly effective in motivating significant numbers of Americans to have conversations with their physicians . . . especially for important undiagnosed, under-diagnosed and under-treated conditions . . .  such as high cholesterol, depression and high blood pressure.  

## BACK-UP

## Ensuring DTC Ads Continue to Be a Valuable Resource for Consumers

- Understand and address significant patient barriers
- Use multiple information channels
- Provide information that is accessible and  understandable
- Inform but do not deter
- Reinforce the patient/healthcare provider partnership
- Improve but do not sacrifice proven publichealth benefits

## Communicating with Consumers

**Patient/Healthcare Provider ****Partnership**** **

**Motivating ****Actions**

**Appropriate Diagnosis and Treatment**

- To communicate motivating, useful and understandable information about medical conditions and treatment options so patients can work with their healthcare providers to make informed decisions about their health and get appropriately diagnosed and treated

***Pfizer’s Consumer Communication Mission***

**Notes:**
[SLIDE 2 – Pfizer’s consumer communications mission]
One of Pfizer’s greatest responsibilities – to our customers and our business – is to communicate information about medical conditions and our products in ways that enable the best health outcomes possible. 
We believe - and research supports - that direct communication with consumers . . . and, more specifically, DTC advertising . . . is an important and effective channel for this information.  Further, we believe that DTC advertising helps patients work with their healthcare providers to make more informed decisions about their health . . .  which, in turn, leads to needed diagnoses, appropriate treatment and, ultimately, better health outcomes.  

## Pfizer DTC Improvements Announced

- Help patients achieve better health by encouraging valuable patient/physician dialogue
- Improve consumer understanding of the risks and benefits of prescription medicines
- Motivate people to overcome barriers to healthy behavior

**“****The leader in the pharmaceutical industry is setting an example for a new era in drug advertising ...” **
***– ******CNBC, 8/11/05 ***** **

**Pfizer to Detail Drugs’ Risks and ****Consult Doctors Earlier**

***Designed to:***

**Notes:**
[SLIDE 13 – DTC improvements]
We can do more to increase the proven public health benefits of DTC advertising.  Despite the many benefits it has provided, Pfizer has heard the concerns expressed about DTC advertising.  And we recognize that more can be done to:
Encourage valuable dialogue between patients and  healthcare providers;
Help consumers better understand the  risks and benefits of prescription medicines; and
Continue to motivate people to overcome potential barriers to better health.
To meet these needs, PhRMA developed guidelines on advertising that all major pharmaceutical companies support and have committed to implementing.  You will see the results – communication of information in clearer language, better balance of risks with medicinal benefits, more relevant information that research tells us engages and motivates viewers.  You’ll also see more ads emphasizing overall health awareness and maintenance.  These are just some examples of what the industry is doing to make DTC an even more effective channel for supporting the doctor-patient relationship and enabling better health outcomes.  
At Pfizer, we have taken these efforts a step further.  From our media budget, we have diverted the rough equivalent of financial support for one major medicine to address general public health as a stand-alone “brand,” if you will.  By doing so, we hope to communicate information that supports prevention, compliance and constructive doctor-patient dialogue . . . without mentioning any medicine.  We’re also postponing advertising new medicines until physicians have at least six months to get familiar with them.