Direct-To-Consumer Advertising : Is It Creating Well-Informed or Mislead, Unduly Influenced Patients? Donna Doherty Jeanne Ulmer Leslie Pirtle MHC 750 JH01 March 2008

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http://neatorama.cachefly.net/images/2006-07/vintage-drug-ads.jpg

http://www.cato.org/pubs/regulation/regv29n1/v29n1-7.pdf 1985 FDA issues Guidelines FDA requests voluntary Moratorium 1982 1st D-T-C Rx drug ad in US 1981 13.5% D-T-C ads are on TV 1994 FDA relaxes rules governing TV ads 1997 2000 63.8% D-T-C ads are on TV

FDA Oversight The FDA regulates the promotion of prescription drugs, including the content of DTC advertisements Requires that advertisements present accurate information and fairly represent both the benefits and risks of the drugs being advertised In 1997 the FDA issued draft guidance to clarify and offer options on how these regulations applied to DTC advertisements on radio and television. FDA reviews ads that will reach a wide audience-this includes all TV ads Sent warning letters to violating companies for 5% of ads between 97 and 00 http://content.healthaffairs.org/cgi/content/full/hlthaff.w3.120v1/DC1

The FDA regulates the promotion of prescription drugs, including the content of DTC advertisements

Requires that advertisements present accurate information and fairly represent both the benefits and risks of the drugs being advertised

In 1997 the FDA issued draft guidance to clarify and offer options on how these regulations applied to DTC advertisements on radio and television.

FDA reviews ads that will reach a wide audience-this includes all TV ads

Sent warning letters to violating companies for 5% of ads between 97 and 00

Spending on DTCA 1997-2005 Table 1: Prescription Drug Promotion and Research and Development, 1997-2005. (Source: U.S. Government Accountability Office, Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising ', GAO report Number GAO-07-54, December 14, 2006.  103.3 162.4 86.0 296.4 Total % increase, ‘97-’05 9.3 14.9 9.0 19.6 Avg annual % increase $31.4 not available $7.2 $4.2 2005 $29.8 $15.9 $7.8 $4.0 2004 $27.1 $13.5 $7.4 $3.3 2003 $21.4 $8.5 $5.6 $2.5 2000 $15.5 $6.0 $3.9 $1.1 1997 R & D Retail value of samples Spending on promotion to physicians Spending on DTC advertising Year

Some Facts "Up until 1997, manufacturers could not say both the product's name and what it was used for, in a TV ad" Today, over 196-million consumers have seen a DTC advertisement http://www.magazine.org/Research/7973.cfm

"Up until 1997, manufacturers could not say both the product's name and what it was used for, in a TV ad"

Today, over 196-million consumers have seen a DTC advertisement

http://www.cato.org/pubs/regulation/regv29n1/v29n1-7.pdf, p.3

TV Drug Ads Legal In Only 2 Countries New Zealand United States

New Zealand

United States

Types of D-T-C Ads Product-claim ads Reminder ads Help-seeking ads http://www.fda.gov/fdac/features/2004/404_ads.html

Product-claim ads

Reminder ads

Help-seeking ads

http://www.fda.gov/cder/ddmac/P3Benzing/sld023.htm

http://www.fda.gov/cder/ddmac/P3Benzing/sld023.htm

2 Types of Data Impact of D-T-C advertising on patients Impact of D-T-C advertising on physicians

Impact of D-T-C advertising on patients

Impact of D-T-C advertising on physicians

http://democracyinaction.org/dia/organizations/commercialalert/campaign.jsp?campaign_KEY=1415&t=stop_drug_ads_home.dwt

Pro Direct-To-Consumer Educates Patients Prompts to see physician Prompts patients to talk about conditions they might not otherwise talk or know about Freedom of speech—can’t stop it Ultimately reduces costs by prompting early treatment Alerts patients to disease they were unaware that they had Empowers consumer to become more active participant in their own care

Educates Patients

Prompts to see physician

Prompts patients to talk about conditions they might not otherwise talk or know about

Freedom of speech—can’t stop it

Ultimately reduces costs by prompting early treatment

Alerts patients to disease they were unaware that they had

Empowers consumer to become more active participant in their own care

Pro Arguments-Consumers Nearly two-thirds of consumers agree that DTC advertising is done responsibly Approximately two-thirds of consumers have talked with their doctors about a prescription drug as a result of DTC advertising. Approximately 20-million have had three or more of these conversations 2002/1 in 5 Americans were prompted to contact MD to discuss a D-T-C advertised drug (Gottlieb,BMJ,2002) 1999, 15.3 million Americans requested D-T-C advertised drugs/12.9 million received the drug,(Mintzes,2001) http://www.magazine.org/Research/7973.cfm

Nearly two-thirds of consumers agree that DTC advertising is done responsibly

Approximately two-thirds of consumers have talked with their doctors about a prescription drug as a result of DTC advertising.

Approximately 20-million have had three or more of these conversations

2002/1 in 5 Americans were prompted to contact MD to discuss a D-T-C advertised drug (Gottlieb,BMJ,2002)

1999, 15.3 million Americans requested D-T-C advertised drugs/12.9 million received the drug,(Mintzes,2001)

Pro Arguments-Doctors Facilitates patient-provider communication Prompts patients to discuss symptoms more openly 41%of MD’s reported improvement in patient awareness of treatment as well as improved discussion, (Aikin et al,2004) 39% of 643 MD’s prescribed a drug requested by a patient as a result of an advertisement 46% of the MD’s who had prescribed a patient requested drug felt it was the most effective treatment for the patient’s condition (Health Affairs,4/04) Promotes need for MD’s to remain educated about drugs to inform patients Prompted patients to see their physician Strengthens provider-patient bond

Facilitates patient-provider communication

Prompts patients to discuss symptoms more openly

41%of MD’s reported improvement in patient awareness of treatment as well as improved discussion, (Aikin et al,2004)

39% of 643 MD’s prescribed a drug requested by a patient as a result of an advertisement

46% of the MD’s who had prescribed a patient requested drug felt it was the most effective treatment for the patient’s condition (Health Affairs,4/04)

Promotes need for MD’s to remain educated about drugs to inform patients

Prompted patients to see their physician

Strengthens provider-patient bond

Pro Arguments-Rx Industry Its patients right to know and choose Empowers patients w/information Urge patients to seek treatment Promotes early treatment and diagnosis and reduces spending on medical services such as hospitalization

Its patients right to know and choose

Empowers patients w/information

Urge patients to seek treatment

Promotes early treatment and diagnosis and reduces spending on medical services such as hospitalization

DTC communications about prescription medicines serve the public health by: Increasing awareness about diseases Educating patients about treatment options Motivating patients to contact their physicians & engage in a dialogue about health concerns Increasing the likelihood that patients will receive appropriate care for conditions that are frequently under-diagnosed and under-treated Encouraging compliance with prescription drug treatment regimens.

Increasing awareness about diseases

Educating patients about treatment options

Motivating patients to contact their physicians & engage in a dialogue about health concerns

Increasing the likelihood that patients will receive appropriate care for conditions that are frequently under-diagnosed and under-treated

Encouraging compliance with prescription drug treatment regimens.

The Pharmaceutical Research and Manufacturers of America (PhRMA) Premise of the Principles Compliance with FDA Regulations Responsible Education about the Medicine and/or Health Condition Clear Indication that the Medicine is a Prescription Drug Encouragement of Communication between Patients and Health Care Providers Education of Health Care Providers Prior to Launch of Advertising Campaign Alteration or Discontinuation of an Advertising Campaign

Premise of the Principles

Compliance with FDA Regulations

Responsible Education about the Medicine and/or Health Condition

Clear Indication that the Medicine is a Prescription Drug

Encouragement of Communication between Patients and Health Care Providers

Education of Health Care Providers Prior to Launch of Advertising Campaign

Alteration or Discontinuation of an Advertising Campaign

The Pharmaceutical Research and Manufacturers of America (PhRMA) Submission of DTC Television Advertisements to the FDA Prior to Broadcast Information on Other Treatment Options Information about the Medicine’s Approved Purpose and Major Risks Balanced Representation of Benefits and Risks Respect for the Seriousness of the Medicine and Health Condition Avoiding Audiences that are Not Age-Appropriate Promotion of Health and Disease Awareness Information about Help for the Uninsured and Underinsured

Submission of DTC Television Advertisements to the FDA Prior to Broadcast

Information on Other Treatment Options

Information about the Medicine’s Approved Purpose and Major Risks

Balanced Representation of Benefits and Risks

Respect for the Seriousness of the Medicine and Health Condition

Avoiding Audiences that are Not Age-Appropriate

Promotion of Health and Disease Awareness

Information about Help for the Uninsured and Underinsured

Cons… Appeals to emotions Misleading Understates risks & side effects Benefits are overstated Influences patients to ask for meds they don’t need Spend money on brand names

Appeals to emotions

Misleading

Understates risks & side effects

Benefits are overstated

Influences patients to ask for meds they don’t need

Spend money on brand names

Cons… Conditions that aren’t conditions physicians under pressure to prescribe drugs unnecessarily. Undermines physician-patient agency relationship Bribery from drug companies

Conditions that aren’t conditions

physicians under pressure to prescribe drugs unnecessarily.

Undermines physician-patient agency relationship

Bribery from drug companies

Cons… Telling healthy patients they are sick! Consumers lack the safety and efficacy information they need to make informed decisions FDA oversight is too weak

Telling healthy patients they are sick!

Consumers lack the safety and efficacy information they need to make informed decisions

FDA oversight is too weak

Prevention vs Risk Reduction

Making Health Decisions Based On TV…

US$1.20 US$2.20 US$3.20 US$4.20 Its Quiz Time...

In the year 2000, how much did each dollar spent on direct-to-consumer advertising of prescription drugs in the United States yield in additional pharmaceutical sales? US $1.20 US $2.20 US $3.20 US $4.20 http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0030239&step=question&qid=Q1&x=34&y=21

US $1.20

US $2.20

US $3.20

US $4.20

26% Based on the 2003 European guidelines on cardiovascular disease prevention, what proportion of Norwegian adults would be labeled as having an “unfavorable” cardiovascular risk profile? 56% 76%

26%

56%

76%

US $25 million US $85 million US $125 million How much did drug companies spend in 2004 in Europe on “disease awareness” campaigns (unbranded disease-specific consumer advertising)?

US $25 million

US $85 million

US $125 million

20% The Pfizer Web site states that sildenafil (Viagra) “works” for what proportion of men? 40% 60% 80% 100%

20%

40%

60%

80%

100%

10%–20% of the time 50%–60% of the time 80%–90% of the time On its Web site, Pfizer states, “VIAGRA can work for you. In fact, studies show that VIAGRA works for more than 80% of men with ED [erectile dysfunction] taking VIAGRA 100 mg versus 24% of men taking a sugar pill” ?

10%–20% of the time

50%–60% of the time

80%–90% of the time

Men between the ages of 18 and 45 years Men between the ages of 45 and 60 years Men over 60 years Between 1998 and 2002, the group showing the largest increase in Viagra use was men between the ages of 18 and 45, and only one-third of these men had a possible etiologic reason for needing Viagra

Men between the ages of 18 and 45 years

Men between the ages of 45 and 60 years

Men over 60 years

There is good evidence from long-term studies that these drugs can improve the quality of life of people with Alzheimer disease Memantine is a good option for all patients with Alzheimer disease Donepezil, galantamine, and rivastigmine should be reserved only for people with Alzheimer disease of moderate severity (i.e., those with a Mini-Mental State Examination (MMSE) score between ten and 20) Which of the following best reflects the latest Appraisal Consultation Document from the United Kingdom National Institute for Health and Clinical Excellence (NICE) on prescribing cholinesterase inhibitors?

There is good evidence from long-term studies that these drugs can improve the quality of life of people with Alzheimer disease

Memantine is a good option for all patients with Alzheimer disease

Donepezil, galantamine, and rivastigmine should be reserved only for people with Alzheimer disease of moderate severity (i.e., those with a Mini-Mental State Examination (MMSE) score between ten and 20)

The drug has been approved in Europe, Australia, and the US The European Medicines Evaluation Agency refused to approve fluoxetine for PMDD The Australian federal government agreed to cover the costs of Sarafem Eli Lilly's advertising of Sarafem has never been in violation of US law Which of the following is true about fluoxetine (Sarafem), a treatment for “premenstrual dysphoric disorder” (PMDD)?

The drug has been approved in Europe, Australia, and the US

The European Medicines Evaluation Agency refused to approve fluoxetine for PMDD

The Australian federal government agreed to cover the costs of Sarafem

Eli Lilly's advertising of Sarafem has never been in violation of US law

13% 23% 33% 43% According to a widely cited 1999 study in the Journal of the American Medical Association on the prevalence of female sexual dysfunction by Laumann and colleagues, what proportion of women aged 18–59 years suffers from female sexual dysfunction?

13%

23%

33%

43%

Pfizer attempted to have sildenafil (Viagra) approved to treat female sexual arousal disorder, but its quest ended because of consistently poor clinical trial results There are no reports of Viagra being prescribed to women off label In 2004, an FDA advisory panel voted unanimously to approve a testosterone patch for women (Intrinsa) to treat “hypoactive sexual desire disorder” Which one of the following statements is true about drug treatments for female sexual dysfunction?

Pfizer attempted to have sildenafil (Viagra) approved to treat female sexual arousal disorder, but its quest ended because of consistently poor clinical trial results

There are no reports of Viagra being prescribed to women off label

In 2004, an FDA advisory panel voted unanimously to approve a testosterone patch for women (Intrinsa) to treat “hypoactive sexual desire disorder”

Warning…..This lecture has been known to cause hair raising experiences in a small percentage of the population. If this side effect should occur seek the advice of a professional Beautician immediately or visit your doctor and ask for a DTC drug!